‘Bai sr quin mugie CHXHCN Viet Nam tai Hoa Ki Embassy of the S.R of Vietnam in the United States of America CHUNG NHAN/HQP PHAP HOA LANH SY CONSULAR AUTHENTICATION 1. Quée gia Country Gify t, tai ligu may This public document 2. do Ong/Ba STEVE SIMON ky Has been signed by . 3. véi chire danh: BO TRUONG NGOAI GIAO ‘acting in the capacity of | Secretary of State 4. vacon du cia BANG MINNESOTA bears the seal/stamp of State of MINNESOTA urge chimmg nh§n/hop php héa lanh sy ified Certifie 5. tgi Washington D.C, Hoa Ky 6. ngay 14 thang 12 nim 2015 At Washingion DC the (dd/mmiyy) 7. Co quan cdp: Dai sit quiin nude CHXHCN Vit Nam tai Hoa Ky By Embassy of the S.R of Vietnam in the United States of America 8, S6/No. 3748 JHPH2015BAN DICH Bang Minnesota NGOAI GIAO GIAY CHUNG NHAN CONG VU Téi, STEVE SIMON, B@ truéng Ngoai giao Bang Minnesota ching nhan ring: Ngudi cé tén dudi diy, véi chi ky trén tai ligu kém theo, la ngudi dimg dau van phong c6 tén duéi day va li ngudi cé du tu céch va duge ty quyén ding ddu vin phng dé va thyc hign cdc chire ning cia vin phong dé, vio ngay ma van ban dinh kém duge ky. HQ VA TEN NGUOI KY: AMJAD AHMAD CHUC VU: Céng chiing vién, Bang Minnesota NGAY KY VAN BAN: 20/11/2015 Gidy chimng nhfn nay duge cap ngay: 20/11/2015. (Da ky’ va déng déu) STEVE SIMON BO trusng Ngoai giao Bang Ching thre ba Nguyén Thi Thy Ha, Téi, Nguyén Thi Thity Ha, Bi thae Thie Bi thw Thie Ba, Dai sit quan CHXHCN Ba, Dai sit quin CHXHCN Vigt Nam tai Viét Nam tai Hop Ching quéc Hoa Ky, dé — Hop Ching quéc Hoa KY, cam doan da Ay trudc mat ti. dich chinh xa van ban nay tie tiéng Anh Ngay 14 thang 12. néim 2015 sang tiéng Viét. Z Bia ‘Ngay 14 thang 12 ndim 2015 \, Nguoi dich 9 ) a 2 Nguyén Thj Thiy HaSECRETARY OF STATE CERTIFICATE OF OFFICE 1, Steve Simon, Secretary of State of Minnesota, do certify that: The person listed below, whose signature appears on the attached document, held the office set forth below and that the person was duly qualified and empowered to hold that office and to perform all of the functions of that office on the date the attached document was signed. NAME OF SIGNING PERSON: Amjad Ahmad OFFICE HELD: Notary Public, State of Minnesota DATE DOCUMENT WAS SIGNED: November 20, 2015 This certificate has been issued on: 11/20/15 LOO OOOO OOO Ss ye , [ive Secretary of State Vy AURORA Ad ve eeDEPARTMENT OF HEALTH & HUMAN SERVICES Pubic Hein Service e Food and Org Adminsation 10803 New Hamstice Averue ‘iver Spring, MO 20099) Certificate No. 2508-4-2015 CERTIFICATE TO FOREIGN GOVERNMENT {In ofder to allow the importation of United States products into foreign countries, the U.S. Food and Drug ‘Administration (FDA) certifies the following information concerning the product(s} to be exported listed below: = ‘Name of Product(s) Name of Manufacturer/Distributor, Address ‘See Attached List Name of Distributor INSITE TECHNOLOGIES, INC. (Two Pages) £589 Phan ie Saint Paul, MN USA 55100 ‘The product(s) described above (and the manutacturing/distribution site(s) which producesidistributes it) is subject to:the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act. {tis cettilied that the above product(s) may be marketed in, and legally exported from, the United States of Amrica at this time. The manufacturing plant(s) in which the product(s) is produced is subject to periocic ingpections. ‘Amjad Ahmad NOTARY PUBLIC ee Division of international Compliance Operations eae Office of Compliance Canter for Devices and Ratioiogicat Health This certificate is valid from April 02, 2015 to Aprit 01, 2017. come «EE ‘Signed or attested befor ‘this _ day of Amjad Aniiad,Notwry Pa My Commissfon Expires January 31, 2019i DEPARTMENT OF HEALTH & HUMAN SERVICES 9 g See Certificate No: 2606-4-2015 Certificate to Foreign Gavernment~ Name of Product(s) Attachment Page 1 of 2 Name of Distributor INSITU TECHNOLOGIES, INC. 1589 Phaien Svs Saint Paul, MN USA'55190 Name ot THATREEA O14" 185em Floppy Anges “116185-FA-H 014" x 185em Floppy Angled (Hydrophilic Coated) “WA185-F3 O14" x 185cm Floppy aight 114185-S-H 014°» 185em Floppy Saight yroptito Costes) ‘11418544 .014" x 185m intermediate Angled {418515 H 044" x 186cm Inrmedint Staight(Hydropile Coated) +114185:87A 014" x 1850m Standard Angie’ 114185-STA-H .014” x 185em Standard Angled (Hydrophilic Coated) ‘414185-STS 016" x 185em Standord Straight {14185-STSH O14" x 185em Standare Svalght (Hycrophilic Cotee) “V44¥B5-XA.014" x 188em Xora Support Angled 114185-XS-H .014” x 185cm X-tra Support Straight (Hydrophilic Coated) -114300-FA. 0147 200em Floppy Angie’ 114300-F4-H .4"x S00er Fapny Angled tyérophile Coated) 114300-FS .014* x 3000m Floppy Straight 11430068. 14° 200em Floppy Straight (yerophile Costes) 114900: 014" x 900em Intermediate Angled 114300-14-H .014" x 300em Intermediate Angled (Hydrophilic Coated) ‘114900418 014" x200em intarmeodints Sight 1490048-H 014” x 300em fnlermediate Straight (Hydrophie Coates) ‘(44200 STA 014" x3000m Standard Angied 414900-STAAH 014", 000m Standard Angled (HydrophilsCosted) 4%4300-STS .014" x 300em Standart Straight 414900.STS-H 014" x 300em Standort Staight (ycropilc Costas) 114300-KA .014" x 300cm X-tra Support Angled 114300-XA-H .014” x 300m X-tra Support Angled (Hydrophilic Coated) 144300-XS 014" x 300cm X-tra Support Streight 444300-XS-H 014" x 300cm X-tra Support Siraight (Hydrophilic Coated) 282180-J 032" x 1600m J Tip PTFE Coated 252180-8 082" x 180em Straight Tp PTFE Coated 2921@0-1,052"x 180em JT PTFE Coated 252180-8 082" 180m Straight Tip PTFE Coated 232260-J 032" x 2800m J Tip PTFE Coated 282080-8 082" x 260c Straight Tip PTFE Coated -238180- .035" x 160cm J Tip PTFE Coated 235150-S_.035" x 1506m Straight Tip PTFE Coated "295101095" x 80cm 1 Tip PTFE Costes 295180-S .035" x 1800m Straight Tip PTFE Coated -235200~1 086" x 200em J Tie PTFE oated 25280-5035" x250em Steight Tip PTFE Costa 2201904) 058" 1800m J Tip PTFE Coated 28150-5038" 180em Steight Tp PTFE Coated 228180.) 038" x 180em J Tip PTFE Coated £290190-S ,038" x 180em Straight Tip PTFE Coatsd 2282804) ,36" x 2600m J Tip PTFE Coated 230260-8 098" x 250em Straight Tip PTFE Coste 218180-STA 016" x 150em Sanda Angled ‘38180-STS 018" x 1s0em Stands Suaight ‘318185-STA 018"x 188em Standard Angled ‘318105:STS 016"x Te5em Standard Svaght ‘348200-STA.048" x 260em Standard Angie’ 348260-S7S .018"x 2600m Standard Straight ‘Amjad Anmad NOTARY PUBLIC Stary Pu My Corimission Expires January 31, 2019aac f DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Seevior Tetmdiag iain < Stations ‘Siver Spring, MO 20903 Certificate No. 2506-4-2015 Certificate to Foreign Government - Name of Product(s) Attachment Page 2 of 2 335160-STA..038" x 1S0m Standard Angled '305160-STS .036" x 1500m Standard Straight 385186-SBA 035" x 185em STIFF BODY Angled ‘335186-SB5 .035"x 18cm STIFF BODY Steight £395186-STA.036" x 185cm Standard Angled {995185-STS .095"x 185m Standard Sireight £335260-SBA 035" x260em STIFF BODY Angled ‘395280-SBS 035" x 260em STIFF BODY Straight '335260-STA..035" x 280cm Stardart Arglet 35280-STS 035" x 280em Standaré Siraighh 388150-STA.038"x {60am Standard Angled '398180-STS..038" x 460em Standard Straight ‘398185-STA..038"x 1880m Standard Angled -996105-STS 038" x {88cm Standard Straight '338280-STA.038"x260cm Standard Angled {$36260-STS..038" x 2800m Standard Straight ne teEEND OF PRODUCT LIS Tonner ‘Ainjad Ahmad NOTARY PUBLIC MINNESOTA, ‘Ainjad Ahimidd, Notary My Commission Expiros January 31, 2019%y,, DEPARTMENT OF HEALTH & HUMAN SERVICES Public Hel Seni i " Toot Ong Adaion ‘ 40903 New Hampshire Avenue ‘Silver Spring, MD 20993 Certificate No, $396-9-2012 (CERTIFICATE OF EXPORTABILITY ISECTION gotte\ty “The Food and Drug Administrtion certifies thet the product/s} desorined below is subject to its Jurisdiction under the Federal Food, Drug, and Cosmetic Act (the Act). The products described below ‘may not be sod or offered forsale in the United States. The company has certified tothe Food-end Drug ‘Administration that: ‘the produet{s) accords tothe specifications of the foreign purchaser, ‘the products) is not n confct withthe laws of the country to which itis intended for export 1+ the shipping package forthe product(s) is labeled on the outside that i is intended for expost and «+ the product(s ts not sold or offered for sale in the United States. Based on the information above, the products) listed below may be exported pursuant fo Section e01(e)1) of he Act. NAMEOFPRODUCT -==———SsNAME. OF COMPANY, ADDRESS ‘See Attached List InSity Technologies® Inc. (Page) ‘599 Phalen Blvd. oma td = ANN Signed or attested: before me’ this _2O day of Director Division of Risk: Management Operations ‘Office of Compliance Genter for Devices and Radislegical Health ‘This certificate expires 24 months, trom the date notarized. ‘COUNTY OF MONTGOMERY 'STATE OF MARYLAND ‘Subserbed and awom to before methis 7 day of OCI month 2012 year. NOTARY PUBLIC MINNESOTA, SATHANA MORRIS NAY BLELIE SATE Gr MARYLAND 2 Comes Egret 42038. Certificate of Exportabilty (Section 801)~ Attachment Page 1 of 1 Neme of Products) = a. ‘diate InSitu Technologies® inc. forqua™ Desioe: 639 Phelen Bivd. % St. Paul, MN 55130 USA. InSite S-way Stopcock InSitu Hemostasis™ Valve WwSitu Easy Cath™ InSitu Easy Cath™ Kit inSitu Angiographic™ Needle StarFlex"™ Sheath introducer Kit inSitu Sheath™ Intoducer Kit ‘nGitu Guidewire™ Insertion Too! InSiu High Pressure™ Contrast Line Forté Long Balloon Catheler™ Reinbow™ Angiography and Guide Catheter InSituSeal™ Hemostatic Patch System InSitu-Ontrac™ Endoflator InGitu- Intrac™ Endotiator “END OF PRODUCT LIST ‘Amjad Ahmad, Notaty Public My Commission Expires January 31, 2019DEPARTMENT OF HEALTH & HUMAN SERVICES, ‘PublieHeadth Sexviee ood and Dig Aaminisoation 10903 New Hampshire Avence ‘Silver Spring, MD 20993 Certificate No. 27629-12-2018 CERTIFICATE TO FOREIGN GOVERNMENT In order to allow the importation of United States products ino foreign countries, the U.S. Food and Drug ‘Administrator (FDA) certies the folowing information concerning the product(s) to be exported listed ‘ below: ‘Name of Product(s) ‘Name of Distributor, Address Catheter InSitu Technologles® ne insitu OnTrac™ PTCA Endofiator ‘$39 Phalen Bhd. ‘St Paul, Minnesota 55130 USA ‘The product(s) described above (and the rmanufacturing/distribution site(s) which produces/distribuies it) is subject to the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act. Its certified that the above product(s} may be marketed in, and legally exported from, the United States of America af this time. The rhanufacturing piantis) in which the product(s) is produced is. ‘subject to periodic inspections. The last such inspection shaved that the plant(s), at that time, ‘appeared to be in substantial compliance with current good manufacturing practice requirements for ‘he product(s) listed above. ‘Amjad Ahmad fe oS NOTARY PUBLIC ‘Carl Fischer, Ph.D. Director Dixision of tntarrationsl Compliance: Operations: ‘Office of Compliance Center for Devices and Radiological Health 2 ‘This Certificate ts valid from January 26, 2015 to January 26, 2017. STATE OF MINNESOTA County of __ Signed or attested before me this 20 day of Notary Pubiie~ My Commissfon Expirés January 31, 2019eo “sy, DEPARTMENT OF HEALTH & HUMAN SERVICES Publig Health Service Foot and Drug Adnicuaton ‘10903 New Hampshire: Avenue Silver Spring, MD 20993 Certificate No. 25414-1-2014 (CERTIFICATE OF EXPORTABILITY (SECTION 602 ‘he Food and Don Aubin carton tt ty. is) ome bnew ewer to he Jurisdiction under the, Federal Food, Drug, and Cosmetic Act (the Aci). Such product(s), which is-not Sopcrved fr rash foe red Sts roy belly sop pre mechs omega. cof Section 802 of the Act. ‘Under Section 802 of the Act, @ drug or device not approved for marketing in the United States ray be ‘exported fit is manufactured, processea, packaged, and held'in substantial conformity wth current good rmanutacturing practioe requirements. The manufacturing plant(s) in which the product(s) is produced is Subject fo pardi inspections. The iat auch inspection showed that the part) at hat tm, appeared to be in substantial compliance with current. good manufacturing practi requirements for the products) listed below. The company has certfied to the Food and Drug. Administration that: the product(s) accords to the spetifcations of the foreign purchaser; ‘the product(s) is not in conflict wth the laws of the country to which itis intended for export; ‘+ the shipping package for the product(s) i labeled on the outside that itis Intended for export; ane ‘© the producti) is not sold or offered for sale in the United States, ‘Based on the information above, the product(s) listed below may be exported pursuant to Section 802 of the Act ‘Name of Product ‘Manufacturing Location ‘See Attached List InSitu Technologies tn. (Pegs) 538 Palen | St. Paul, MN $5130 USA, ‘Amjad Ahmad NOTARY PUBLIC 4 = tswnesora : Lelia M Lawrence is ‘Chief, Export Branch seca ‘Dyision of international Compliance Operations os Office of Compliance a ‘Center for Devices and Radiological Health ‘This cortiicate expires 24 months, ‘from the date notarized, | - (COUNTY OF MONTGOMERY STATE OF MARYLAND ‘Subscribed and swom to before me this 24 day of F=zo month 2014 yea. \TE OF MIN ras 2 (ow wwe Lepigeges — Cabthescea Ad (Ie CATHY N MORRIE Notary PublieeMarylang Mantgomory County My Comm/ssran Expired Aanuary 04, 2017 I Nota i Notary Public My Commission Expires January 31, 2019Certificate of Exportability (Section 802) ~ Attachment Page 1 of 1 Name of Product(s) Manufacturing Location: DIRECT-STENT® Celosia™ InSitu Technologies” Inc. DIRECT-STENT® Celosia™ Covered Stent 539 Phalen Blvd. + Gelosia™ Coronary Sient ‘St. Paul, MN 55130 Gelosia™ Covered Stent USA. Gelosia™ Coronary Stent-Graft “END OF PRODUCT LIST” ‘Amjad Anmad NOTARY PUBLIC MINNESOTA E OF MINNESOTA,ty, setts DEPARTMENT OF HEALTH & HUMAN SERVICES Public Healt Service Certificate No, 27528-12.2014 Food and Drag Administration 10903 New Hampshire Avenve Silver Spring, MD 20993 CERTIFICATE TO FOREIGN GOVERNMENT In order to allow the importation of United States products into foreign countries, the U.S. Food-and Drug. ‘Administration (FDA) certifes the following information Gonceming the producl(s) 1o be exported listed ¥ below: Name of Productis) ‘Name of Distributor, Address Catheter InSitu Technologies® inc. ‘See Attached List 539 Phalen Blvd. (1 Page) ‘St. Paul, Minnesota 85190 USA. “The product(s) described above (and the manufacturing/distrbution site(s} which praduces/distributes it) is subject to the jurisdiction of the FOA under the Federal Food, Drug, and Cosmetic Act, itis certified that the above product(s) may be marketed in, and legally exported ftom, the United States of America at this ime. The manufacturing plant(s) in which the products) is produced is. subject to periodic inspections. The last such inspection showed that the plent(s), at that time, ‘appeared to be in substantial compliance with current good manufacturing practice requirements for the product(s) listed above. ‘Anjos Annas NOTARY PUBLIC MINNESOTA ee a = - atl Fischer, PRD. Director Division of international Compliance Operations Office of Compliance (Gre Center for Devices and Raciological Healin roe ‘This Certificate Is vaild from January 26, 2016 to January 26, 2017; oie BARE (Wve 0 , Notary Public iy Commecen Expires January 31, 2019Certificate to Foreign Government — Attachment (Page | of 1) Natne of Product(s) Ne oh Ditton, os, StncFlex™ Sheath Introducer . ‘InGitn Techuslogies® Inc. StacFlex™ Sheath Introducer Kit: 539 Phaien Bivd. . St, Paul, Minnesota’55130 USA (Sheath Introducer) ‘Amjad Abmad ‘Amjad himad, Notary Public My Commiggion Expires January 31, 2019nen, ane “Sn ‘DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Dg Adminisration 110903 New Hampshire Avenue Silver Spring, MD 20993 Cortificate No. 25413-1-2014 CERTIFICATE OF EXPORTABILITY (SECTION 802) The Food and Drug. Administration ceriies that the (6) desciibed below is subject to its Jurisdiction under the Federal Food, Drug, and Cosmetic Act (he Act). Such product(s), which is not ~ ‘approved for marketing in the United States, may be legally exported providedt masts the requirements a ‘of Section 802 of the Act, ‘Under Section 802 of he Act, a drug or davice not approved for marketing in the United States may be Soe ee ed ee ee ae ‘manufacturing praotice requirements. The:manutecturing plant(s) in which the product(s) is is ‘subject to periodic inspections. The last such inspection showed that the plant(e), at that time, appeared ‘0 be in substantial eompfonce wih curent good manufacturing practice requirements for the product(s) sted below. The company has certified to the Food and Drug Administration that: ‘+ ‘the product(s): accords to the specifications ofthe foreign purchaser; ‘+ the product(s) is notin confict withthe laws of the county to which itis intended for: exports + the hippie pene forte pod) lable an ets a tnd or por ++ the products) is not sold'or offered forsale in the United States. Ee to loans, hs acta a aoe maybe eet ato en OO et the Act, ‘Name of Product ‘See Anached List {1 Page) = Amjad Ahmad v NOTARY PUBLIC MINNESOTA Leila M. Lawrence ‘Chief, Export Branch Division of International Compliance Operations Ottice of Compliance ‘Center for Devices and Radiological Health ‘This certificate expires 24 months. trom the date notarized. : : ‘COUNTY OF MONTGOMERY ‘STATE OF MARYLAND. ‘Subscribed and swom to betore me this 24 day of Fe 4o month 2044 year. thr, WZ -4or— Arnau N MORRIS Notary Puble-Maryland Montgomery County My Commiustan Exaices Sonuary 04. 2012a Certificate of Exportability (Section 802) ~ Attachment Page'1 of 1 Name of Product(s) Manufacturing Location: DIRECT-STENT® Silene™ Init Technolagies® Inc. DIRECT-STENT® Silene™ Covered Stent 839 Phaien Bivd. ‘Silene™ Peripheral Stent St. Paul, MN.55130 Silene™ Peripheral Stent USA, Silené™ Peripheral Stent-Graft “END OF PRODUCT LIST” Amjad Ahmad NOTARY PUBLIC MINNESOTA Finjad ARimaG/ My Commission Expires January 31, 2048no Fa" County of Signed or atjested befor py ; DEPARTMENT OF HEALTH & HUMAN SERVICES ‘ue Meh Sandee \s ‘ood! ad Dog Administration, 10008 New Hempshire Avenue ‘iver Spring, MO-20093 Certificate No. 1756-3-2015 CERTIFICATE OF EXPORTABILITY SECTION 802 ‘The Food and Drug Administration certifies that the product(s) described below is subject to ts jurisdiction under the Federal Food, Drug, afd Cosmetics Act (the Act). Such product(s), which is not approved for marketing in the {Untied States; may be lege export to Toreian canbtes proved Inmate the requrernei of Sao 2 of Under Section 802 of'the Act, a drug or device not approved for marketing in the United’States may be exported if itis manufactured, processed, packaged, and field in substantial conformity with current good manufacturing practice fequirements, The manufacturing plant(s) in which the product(s) is produced is subject to periodic Ingpactons. ‘The last such inepection shawed tat ihe plans), tat time, sppeered to be In substan omplance th current goad mavutactuxng practice requirments forthe pred) tated Below. The company fas cerfied to tre Food and Orug Adminiegavon ist * the product(s) accords to the specifications of the foreign purchaser, * the product(s) is not in contict wth the laws of the county to which its intended for export * she Shipping package forthe product) is labeled on the ouside hat is intended for exper; + "Re prods) ot solder ffared forsale nthe United States Basect on the information above, the product(s) listed below may be exported pursuant to Section 802 of the Act. Name of Product Manufacturing Location ‘See-Attached List INSITU TECHNOLOGIES, INC. (11 Pages) 839 Phalen Blvd Saint Paul, MN USA'55130 ‘ya And ee NOTARY PUBLIC i ae MINNESOTA, aes i Gait Fischer, Ph.D. es ate 20) freon Division of Intemational Compliance Operations Office of Compliance Genter for Devices and Radiological Health ‘This certificate is valid from March 06, 2015 to March 05, 2017. ‘STATE OF MINNESOTA Ka— ‘Certificate No, 1756-3-2015 Food sad Dray Admiristation 080 New Hampshire Avene “y é DEPARTMENT OF HEALTH & HUMAN SERVICES abe Heth Sener i z ee ‘Silver Spring, MO 20983 Certificate of Exportability Section 802 - Name of Product(s) Attachment Page 4 of 11 Manufacturing Location INSITU TECHNOLOGIES, INC. '§30 Phin Bus ‘Saint Paul, MN USA'5SI30 Name ‘622510 Ceiosia Coveres Cofonay Sent 226.810 7822513 Colosia Covered Coronary Stent 225%:13 7622516 Celosia Covered Coronary Stent 2.25x16 7822518 Cetosa Covered Coronary Sient 225319 7622523 Celosia Covered Coronary Stent 2.25x23 7022826 Celosa Covered Coronary Stent 225328 7622530 Colosia Covered Coronary Stent 2.25'x 30 162810 Colsia Covers Coronery Stent 25% 10 762519 Celsia Covered Coronary Stent 2.5% 13 742516 Gelesia Covered Coronary Stent 25% 18 762519 Colosia Covered Coronary Stent 2.5% 19 762529:Cebsia Coveted Coronary Stent 25.23 1762508 Celsia Covered Coronary Stent 25x26 762590 Celosia Coveted Coronary Stent 25x90 762534 Ceiosia Covered Coronary Stent 2.x 34 762598 Calosia Covered Coronary Stent 2.538 7627510 Celosia Covered Coronary Stent 275% 10 7627513 Celeia Coveres Coronary Stent 2.78% 19 7627S16 Celoia Covered Coronary Stent 2763 18 74Q7EA8 Gelosia Covered Coronary Stent 2.75% 19 7627523 Celosia Covered Coronary Stent 2.75 «23 7827528 Celoia Covered Coronary Start 2.75328 ‘827530 Colosia Covered Coconary Stent 2.76% 30 7627594 Ceisia Covered Covonay Stent 275334 7627538 Cebosia Covared Coronary Stent 2.75338 763010 Celosie Covered Coronary Stent 3.0 10 763013 Celosia Covered Coronary Stent 3.0.x 13 ‘763016 Celosie Covered Coronary Stent 30x16 763010 Cetsls Covered Coronaty Stent 3.0419 ‘163023 Celosia Covered Coronary Stent 3.0% 23 763026 Gelosia Coveres Coronary Sten! 3.0% 28 73030 Golosia Covered Coronary Stent 30x30, 769034 Celaaia Covered Coronary Stent 30% 84 769088 Gaosia Goveres Coronary Stent 30x28 TEB5H0 Calsia Coveres Coronary Stent 2.5.10 783513 Geosia Goveres Coronary Stent 3.5% 13 763516 Celosin Covered Coronary Stent 252 18 763619 Colosia Covers Gorenay Stent 3.8% 19, 163523 Celesia Covered Coronary Stent 3.8%23 163828 Celosia Covered Coronary Stent 25%26 783880 Coesia Covered Coronary Sant 35x20 763894 Colonia Covered Coronary Stent 98X24 763538 Celosia Covered Coronary Stent 35x 38 704010 Cetosia Covered Coronary Stent 4.0x 10 764013 Colosia Covered Coronary Stent 4.0% 18. 7o4016 Celosia Covered Goronary Stent 4.0% 16 764019 Gelosia Covers Corenay Steni 40x 19, 764023 Catesia Covered Coronary Stent 4.04.23, 784028 Celosla Cavers Coronary Stent 4.0% 28 “TeA030 Coosia Covered Goconery Stn. 4.0% 30 ‘764034 Gelosia Covered Coronary Stent 4.0.x 34 ‘Amjad Ahmad NOTARY PUBLIC AINNESOTA STATE OF MINNESOTA County «any nea ed before mé this 2D) day of OVE pe / ‘Amjad Kinfad, Notary P My Compfission Expires January 31, 2019Pile Heath Serie if Y veparrment or HEALTH & HUMANSERVICES i ae Cortificata No. 1786-3.2018 Certificate of Exportability Section 802 -Name of Product(s) Attachment Page 2 of 11 764098 Celosi Covered Coronary Stent 40x 38 764515 Colocia Covered Soranary Sent 45% 15 "764819 Getosia Covered Coronary Sient 4.5 19 1784523 Celosie Covered Coronary Stent 45x23 764828 Ceosia Covered Coronary Stent 45x26 1784590 Celosia Covered Coronary Stent 48 x.30 788534 Gelosia Covered Coronary Stat 4:5.x34 784538 Gelosia Covered Coronary Slat 48x38 765015 Celosia Covered Coronary Stent 50.15 785018 Gelosia Covered Coronary Stent 80x18 1765024 Colosia Covered Coronary Stant 5.03% 24 795080 Gelosia Covered Coronary Stent 030 173506 Gelosia Covered Coronary Ste 80% 35 1765038 Gelosia Covered Coronary Stent 5.0338 788018 Gelosia Covered Coronary Stont 80x15 1788080 Gelosia Covered Coronary Sto 80x30 1768033 Colosia Covered Coronary Stent 6.0% 33 765035 Celasia Covered Coronary Stent 6.0% 35. 767014 Calosin Covered Coronary Stent 7.0% 14 TOTO‘4 Celosia Covered Coronary Stent 7.0% 17 707023 Colosia Covered Coronary Stent 70323 707028 Ceosia Covered Coronary Ste! 70 x28 TO7033-Calosia Covered Corcnary Stent 7.0.33 422510 DiectStent Stent Graf $3 Coronary Stant 225310 6422513 Direct Stent Sint Graf SS Coronary Stent 2:25.13 {6422516 Drect- Stent Sient Graf $8 Coronary Sto. 225316 {6422518 Diec-Sient Stet Graft 8S Coronary Stent 225319 6422623 Drec-Stont Stent Graf 8S Coronary Slant 225 223 {642256 Direct Stent Stent Graft SS Coronary Slant. 2.25 x26 6422500 Direct Stent Stent Graft SS Coronary Stent 2.25 30 €42510 DirectSten Stent Graf SS Corenay Stent 25x10 {642513 Direct Stent Stent Ge $$ Goronay Sient 25.13. £62516 Direct Stent Stont Graf SS Coronary Stent 25.18 £62810 Direct Stent Stent Gat 8S Coronary Swit 25319 "842529 Dect ont Stant Graft Cofonary Stent 25x23 612526 Direct Stent Stent Gra 8S Coronary Sten! 25x 28 {842590 Dict Stant Sto Graft 5 Coronay Stent 25x30 £42534 Direct Sten Stent Greft8S Coronary Slest 25x34 162598 Direct Stent Stent Grah 85 Coronary Stent 28x 38 {6427540 Direc Stent Stent Graf SS Ceconary Stent. 2.79%10 ‘SA27513 Dec Stet Stent Gra SS Covonsry Stent 27513 427518 Diet Siri Stet Gra S$ Coronary Stent 275x18 {427619 Dect Stent Sent Graft SS Coronary Stent. 27519 {6427523 Drect-Stant Stont Graft SS Comnary Stent 278 «23 {$2752 Diret-Sent Stent Gra $$ Coronary Stent 275 x28. 6427500 Direct-Sienl Stent Gre $8 Govonay Sten 278339 18427834 Dec Sent Stent Gall SS Coronary Stent 2.752334 427598 Direc Stent Stent Grett SS Coronary Stent 2.75x38 642010 Direct Stent Sint Graf SS Coronary Stent 30% 19 £49013 Direct Stent Stent Graf 8 Cownay Stest 30,13 643016 Dire Sten Sint Graf 8S Coronary Siert 30x 18 {849018 Direct Sten Sin! 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CO Coronary Stent. 2.2530 ‘712510 Dict Stent Sient Graft CC Coronary Stent. 2510 742513 Dect Stont Stent Groh CC Coronary Stent 2.6% 13 712516 Direct-Stent Stent Graf CC Coronary Stent 2.5%16 712519 Direct Stent Stent Graf CG Coronary Stent 25% 18 1712522 Ditect Stent Stent Gra CG Coronary Stent 2.523 712526 Direct Stent Stent Gra GC Coronary Stent 2528 712530 Ovect- Stent Stent Graft CC Coronary Stent 25x30 ‘T1QSQA Diret Stent Stont Graf ©C Coronary Stat 25 x36 712594 Dect Stant Stent Graft CC Coronory Siont 25 x38 7127610 Direct Stent Stent Graft CC Coronary Stent. 275 x10 ‘7127913 rect Stent Stent Grati CC Coronary Stent 2.75% 13 7127516 Doct Stent Stent Gah CC Coronary Slent 27518 7127548 Direct Stent Sle Gret GC Goronay Stent 2.75% 18 7127623 Direct Stent Stent Graft CC Coronary Stent 2.78% 23 17127526 Diet Slent Stent Gra CC Coronary Stent 2.75 +23. ‘127880 Dict Stent Sten Graft CC Coronary Stent. 278% 30 ‘Amjad Abad NOTARY PUBLIC MINNESOTA10008 ew Hampshire Avenue FY DEPARTMENTOF HEALTH & HUMAN SERVICES Publ ea Senin i ead and Ona aenineten ‘She See M683 Certificate No. 4758-3-2018 Certificate of Exportabllity Section 802 -Name of Product(s) Attachment Page 4 of tt 7127594 Direct Sient Stent Gssit CC Coronary Stent 2.75 x24 7127598 Ditwct-Stent Slot Gratt CC Coronary Stent 275% 38 718010 Direct-Stont Stent Geaft CC Conary Stent. 30x 10 ‘719013 Direct-Stent Stent Graft CC Garonary Stent 30x13. 712016 Direc-Stent Stent Graf CC Coronary Stent 3.0% 18. 748018 Direct-Stent Stent Graft CC Coronary Stent 3018 1713028 Direct Stent Stent Graft CC Coronary Stent 3.0423 ‘712026 Dkect-Stert Stent Graft CC Coronary Stent 3.0.26 742080 Direct Stent Stent Graft CC Coronary Siant 30% 30 719034 Direct Stent Stent GraftCO Garonary Stent 20x34 719088 Direct Stent Stent Graf CC Coronary Steot °&.0% 361 719510 Direct-Stent Stent Graft CC Coronary Stent 35x 10 ‘71813 Dect Stent Stent Graft CC Coronary Stont 35x 13. ‘748818 Direct Stent Stont Graft CC Coronary Stent 3.5% 16 "719519 Direct Stent Stent Graft CC Coronary Stent 35 x 18 719529 Direct Stent Stent Graft CC Coronary Stent 35x25 "773528 Difect Stont Stent Graft GC Coronary Stent 35x26 713530 Direct-Stent Stent Graft OC Coronary Stent ‘2.5: 90 Kes Amjad Ahmad ‘749804 Direct Stent Stont Graf CC Coronery Stent 3.5 x34 NOTARY PUBLIC ‘713538 Direct Stent Stent Graft CO Coronary Stent 35x38 ae: MINNESOTA, 714016 Direct Stint Stent Graft CC Coronary Stent 4.0% 10 iy Games Ee Jn 3-200 ‘T1ADSS Die Set Ste aR CC Coro Stent 40x13 ‘e016 Orect-ster sient GrakCC Coronary Stent 40318 1714018 Dioct-Slert ion Graf GC Covnay Sent 40316 ‘71a02s Dies Siar Stent rah GC Gora Siont 40425 714026 Direct-Stent Stent Graft CC Coronary Stent 4.0.x 26 \TE OF MINNESOTA 74080 Dect Sten Sie Grate Cora Stat 40390 comy ot__EAMNSEN Veal ‘14094 Direct-Stent Stent Gratt OC Coronary Stent 40x34 714008 Direct Sten Slont Gra CC Coronary Start 40% 38 Sioned or atentedbefors mp tis 20) day of 714515 Dest stent Stent GraftGC Corny Sient 43.15 114519 DreckStent Stel rah OC Coronary Stent 45418 714523 Drea Stent Stent Gra CC Coronary Sion 4.5223 714506 Dect Stet Sint Gra CC Coronary Sie, <5 x28 714830 bree Stet Stent Gre OC Cororay Stet 48x20 asad Drece-siot Sint GrahCC Corona Start 45% 34 714598 DvesnStan Stent Gra CC Gornary Slot 48.38 719016 Deets Seo Gak.CC Coronary Ser, 60.15 ‘718018 Direct-Stent Stent Graft CC. Coronary Stent 5.078 ‘Tis02e Det Stn tom Gra Cc Coronay Set 50x24 715020 Dreo-stnt Stent Grek Gx Corona Sie) $050 71stR5 Dec Stn Stet Gro CC Corona Sten 8.0535 ‘Meaae DiectStan sient Gia CG Coronary Slent 50%38 “Heot6 let Stent Serv Gian Gc Coronary stent 80x75 ‘716048 Dic.-Sten Stet Gra'CC Coronary tent 80378 T0024 bret Sion Sie Gra Go Cornary Stet 802 716090 Deo Stent Sten GraftCC Cornay Stent 6420 ‘16035 Dect-sen Sten Gra G& Coronary Sten 8.0%33 ‘116025 Direct-Stent Stent Graft CC Coronary Stent 6,0x35 717044 Diese Sen Str GraflCC Germany Sint TD 4 ‘7017 Oct Sen Sten: GratCO Corona Sttt TDA 17 717020 Dre Sat Stn GraftGC Goons} Sink 70423 1717028 Oreet Stent Stat Gre 26 Coot Sek 70% 28 717038 Dect Stent Str! GraftCC Coronary Stent 70333 7022510 Drea Sant SRO Selim Eiting Garnet Sent 225.210 17022513 Det Siont SRO Stross ExtingOornay Slr 225513 17022516 Dect Sten SIRO Stelimis Eng Coronary Start 22518 7022519 Die Sot SIRO Stel Eng Coronary Sent 22539 7022523 Des Sten SIRO Seems Eng Crenay Sant 225% 28 ‘Rinjad Ahmad, Notary My Commission Expires/January 31, 2019Pill Heels Seven f ¢ DEPARTMENT OF HEALTH ic HUMAN SERVICES 5 “Ser : Certificate No. 1756-3-2015 ead a Org irisraton 10002 New Hampenra Avene “Sher Spring: MD 20888 Certificate of Exportability Section 802 - Name of Product(s) Attachment Page S of 11, 7022526 OrecSert SIRO Sicfimus Eutng Coronary Stent 225325 7022530 Ovect Stent SIRO Steams Eutng Carensy Stent 2.25.30 702510 DicectStent SIRO Stcimus Euing Coronary Stent 2810 70251 Dirt Sten SIRO Stelmus Eutng Coronary Stent 2513 702546 Direct Sten SIRO Stolmus Euing Covonsiy Sent 25x 18 702510 Direct Stent SIRO Siolmus Ekting Coronary Sent 26x 19. 702528 Dect Stet SIRO Siolinus Eusing Coronary Stent 25328 702526 Dict Stent SIRO Stoimus Exing Coreary Stank 25x28 702830 Direct Sient SIRO Siolimus Euing Coronary Stent 25 x30 702594 Direct Stent SIRO Sioimus Euting Carorary Stet 25x34 702644 Direct Stent SIRO Solus Euting Coronary Stent 25x44 702548 Direct Stent SIRO Sirolimus Eating Coronary Stent 25348 702598 Direct Stent SIRO Sioimus Euting Goronary Stent 2838 7027510 Diret Stent SIRO Sirimus Eiing Gorenary Stent 2.7510 7027813 Ditec Sent SIRO Siolmus Euog Corona Stet 278513 70QzS18 Dect Sent SIRO Sioimus Ehing Coroner Sint 2.75.18 7027519 Direc Stent SIRO Sirolimus Eusing Coronary Stent. 2.75 x19 17621523 Direct Stent SIRO Sioimus Euing Sronar Stent 2.7523 7027528 Direct Sent SIRO Siolmus Euling Coronary Stent 2.75 x28 11027530 Det Stent SIRO Sirimus Eutng Coronary Ste 2.7530 7027594 Diet Stent SIRO Sirolimus Euing Coroner Stent 3.78 x34 7027508 Oe Stent SIRO Sirimus Ehting Coronary Sir 275138 70354 DrectSient SIRO Siolinus Ekting Corenay ten: 275344 703548 Direct Stent SIRO Stofmus Exile Gorenary Sent 275.48 709010 Dect Stent SIRO Stolmus Ekting Coronary Stont 80x10 702013 Direct Stent SIRO Sresnws Exilng Gorenay Stnt 20% 13 703018 Direct Stent SIRO Situs Ehtig Coronary Stak $0x 18 7090t0 Direct Stent SIRO Siosmus Ektlg Coronary Stent 3019 703018 Direct Stent SIRO Siotmus Edting Gorenary Stent 30x23 708028 Direct Sion SIRO Slolimus Eusing Coronary Stent 2.0325 702028 Direct Sten SIRO Sinus Ebling Coronary Stent 2.0 x30 763025 Direct Stent SIRO Stobmus Eharg Coronary Stent 20x34 17030265 DrectStent SIRO Stofmit Ekting Covenary Stent 2.0338 1709534 Direct Stent SIRO Stolmus Eutng Coroner Stent 36310 703594 DirctSien SIRO Sirolimus Ekang Coronary Stent 3.5313 702634 Direct Sont SIRO Siolirus Eking Cornary Stent 35x 16 G95 Dire Stent SIRO Sinus Euting Coronary Stent 35318 03594 Direc Stent SIRO Solus Edsing Coronary Siam 25223 703534 Direct Sient SIRO Siolimus Ekting Coronary Stent 2.5%26 703594 Direct Stent SIRO Situs Ensing Coronary Stent 353%20 709594 Direct Stent SIRO Srolimus Ehsing Grenary Sent 353x334 708538 Dtet Stent SIRO Sioimus Eling Coronary Sint 25338 ‘T0a544 Direct Stent SIRO Sic Euiing Coronay Siet 35x46 03548 Dect Stent SIRO Sian Eling Coronary Siem. 35x48 7OADID DitectStent SIRO Sirolimus Ehiing Coronary Stent 40x10 ‘To4GY3 Direct Stent SIRO Sirois Ehting Coronary Stent. 40313 704018 Direct Stent SIRO Sirolimus Eating Coronary Stent 40x18 ‘To4at8 Oret Stent SIRO Srolmus Eusing Coronary Sent 40x 19 704028 Diect Stent SIRO Srokmus Ekting Coronary Sent 4.023 704026 Direct-Stet SIRO Solus Ekiing Coronary Stent 40x25 704030 Dieet Stent SIRO Siroirs Ektng Coronary Stent 4020 704034 Direct Stent SIRO Stolimus Ehting Coronary Sint 40324 7040Se Drect-Stent SIRO Stolimus Eng Coronary Stent 4.028 704518 Drect Stent SIRO Skelimus Eling Coronary Stent 48215 704519 Drec-Stont SIRO Srolmus Eitng Goronary Stent 453.19 ‘704523 Dost Stont SIRO Sirimus Ewing Corenaiy Stat 483.23 704526 Dict Stent SIRO Sirolimus Ening Coronary Stent 4528 ‘704830 Direct Stent SIRO Sirolimus Eluting Coronary Stent 4.5 ».30 ‘Amnjad Ahmad NOTARY PUBLIC MINNESOTA,A rs ube Heath Borde y if ‘DEPARTMENT OF HEALTH & HUMAN SERVICES SS Contificate No. 1786-8.2045 Food and Drag Aeministaton 1003 Nei Hampshire Avenue ‘iver Spring, MO 20085 Gertificate of Exportability Section 802 - Name of Product(s) Attachment Page 8 of 41 704534 Direct Stont SIRO Skolimus Eling Coronary Stent 45x34 16222810 Direct Stent CC Coronary Stent 2.28 10 (6222513 Direct Stent CC Coronary Stent 2.25 x13 (6222518 Direc Stent CC Coronary Sent 2.25% 18 16222519 Direct Siont CC-Coronary Stent 2.28 x19 16222523 Direc-Stent CC Coronary Stent 2.25 x23 {8220528 Direct Stent CC Coronary Stent 2.25 x26 16222830 Direck Stent CC Coronary Stont 2.26 x30 1622510 Direct Stent CC Goranary Stent 25% 10 (022813 Diwct Stonl CC Coronary Stent 25% 13 62256 Direct Stent CC Coronary Stent 2.5% 16. 1622518 Direct Stent CC Coronary Sten 25x18 622523 Direct Stent CC Coronary Stent 25x23 (622528 Direct Stat CC Coronary Stent 25x28 (622590 Dist Stent CC Coronary Stent 2530 1622534 Diet Stent CC Coronary Stent 25x34 {622598-Ditet Stent CC Goronary Stent 2.538 (8227510 Direct Stent CC Coronary Stent 27810 {6227513 DirectStent CC Coronary Stent 278% 19 8227818 Direck2- 94 CC Coronagy Sent 275% 18 (6227519 Direct Stent CC Coronary Stent 2.78% 19 8227823 DireeStent CC Coronary Stent 275229 {6227528 Direct Stent CC Coronary Stent 2.75% 28 (6227830 Diroc-Siant CC Coronary Stont 275% 30 16227534 Direct Stent CC Coronary Stent 2.78% 34 16227536 Direct Stent CO Corona Stent 278%38 623010 Ditect Stent CC Coronary Stont 3.0% 10 628013 Direct Stent 06 Coronary Stent 30x13 823018 Direct Son CC Coronary Stent 3.0% 18 22019 Direct-Stent CC Goronary Stent 3.0% 12 {825028 Diract Stan GC Coronary Sten! 5.0% 22 629028 Oiect Stent CC Coronary Sten! 3.0% 25 1629080 Direct Stent GC Gotonary Stent 5.0% 30 (623006 DiectStent GC Coronary Sten! 3.0% 34 622038 Direct Stent CC Coronary Stent 3.0% 38 623510 Direct Stent CC Coronary Sient 35x 10 (62353 Direct Stent CC Coronary Stent 3.513 1828516 Direct Stent CC Coronary Stent 3.5.18 629519 DirectSteot CC Coronary Stent $.5%18 1820523 Direct Stent CC Coronary Stent:'35223 623526 Direct Steat GC Coronary Stent 3.5% 25 623550 Direct Stent CC Garerary Stent 35230 1623536 Direct Stent CC Coronary Stent 3.534 (623538 Direct Stent CC Corenary Stent 3.5138 624010 Oreot-Stent GC Coronary Stent 4.0% 10 624043 Direct Stent GO Coronary Stent 40313 (824018 Direct Stent CG Coronary Stent 4.076 {824019 Direct Stont CC Coronary Sent 40x 18 ‘824023 Direc Stent OC Covanary Stent 40x23 £24028 Direct Siant CC Cottnry Stent 4.0% 28 6624030 Dect Stent GC Coronary Stent 40x30 624094 Direct Stent CG Coronary Stent 40x34 {824038 Direct Sten! 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DEPARTMENT OF HEALTH & HUMAN SERVICES is & en Certificate No. 17963-2018 Pull Heal Seen oad ang Oro9 Admoisrabon 10603 New Hampshire enwe ‘ives Spring, MO 20889 Gentificate of Exportability Section #02 - Name of Product(s) Attachment Page 7 of 11 16232528 Drec-Stant SS Coronary Stant 2.25 28 {8320500 Direct-Stent 8S Coronery Stent 225° 30) 1652510 Direct-Stent SS Coronary Stent 25% 10 692518 Direct Stent SS Coronary Stent 25% 13 1882516 Direct Stent SS.Coronary Stent 25% 16 ‘832519 Direc Stent $8 Coronary Stent 252 19 32523 Direct Stent 8S Coronary Stent 25x23 1682528 Direct Stont SS Coronsry Stent 2.526 {632530 Diret Stent 85 Coronary Stent 2530 1832594 Direct Stent SS Coronary Stent 25x24 1682558 Direct Stont $$ Coronary Sion, 2.638 {8327510 Direct Stent $$ Coronary Stent 27510, 16327519 Direct Stent $$ Coronary Stent 275% 13, {8327518 Direct Stent SS Coronary Stent 2.78 x 16 18827519 Drech Sten SS Coronary Stent 278x 19 ‘6227523 DireerStant 8S Coronary Stent 2.78323 (6827826 Direct Stent $5 Coronary Stent 2.7525 {6827530 Direct Stent 8S Coronary Stent 275 20 (6827834 Diret Stent $5 Coronary Stent 2.75 x24 627538 Direct Siant 8S Coronary Stent 275 x28 82010 Diet Stent SS Coronary Sant 3.6 10 1658019 Direct Stent $$ Coronary Stan! 8.0313 1889046 Direct Stent SS Coronay) Stent 3016 633019 Ditect Stent SS Coronary Sen 3019 1629023 Dirset Stent SS Coronary Stent 30x23 £692026 Direct Stent SS Coronary Stent 30x26 39030 Direct Stent SS Coronary Stent 30x30 633034 Dect Stent SS Coronary Stent 30.34 {833038 Direct Stent SS Coronary Stent 3.0538 {833510 Direct Sten! SS Coronary Stent 35% 10 ‘683519 Direc Stent 8S Coronary Stent 3:5 13 "689516 Direct Stent SS Goronary Stent 3.518 ‘833518 Direct Stent SS Coronary Stent 38x 19 1633623 Direct Stent SS Coronary Sient 3.823 '$83528 Direct Sion 8S Coronary Siont 35128 (093590 Ditect Stent SS Gorsnayy Stent 35x20 1833584 Direct Stent SS Coronary Slent 35394 639598 Direct Stent SS Coronary Stent 35x36 ‘834010 Direct Stent SS Coronary Stat 4.0% 70 ‘834018 Direc Stent SS Coronary Stent 40% 19 1634016 Direct Stent 8S Coronary Stent 40% 16 {624018 Direct Stent SS Coronary Stent 40% 19 1894025 Direct Stent BS Coronary Stent 40% 23 1994028 Direct Stent $S Coronary Stone 40%.28 {954090 Direct Start SS Coronary Sion 4.0.30 1834004 Direct Stent $S.Coronary Stent 40:34 {934008 Direct Stent 85 Coronary Stent 4.03.38 {684515 Diamonsiback Bilary Stont 4.5% 15 {864519 Diamondback Bile Stent 4 5% 18 (684523 Diamondback Bilary Stent 45 x23 (984526 Diamonaback Bary Slant 4.5.28 684520 Diamondback Bilary Stont 4.8% 90 ‘904934 Diamondback Bilary Sient 45x34 824528 Dlamonaback Bilary Stent 4.538 {685015 Diamondbeck Bilary Stent 60% 15 1688018 Diamondback Bary Slent 5.0% 18 (685024 Diamondback Bary Stent 50x 24 1885030 Diamondback Biliary Stent, 5.0390 ‘Amjad Ahmad NOTARY PUBLIC MINNESOTA ‘My Commission Expires January 31, 2019no Certificate No. 17563-2015 sen 7 DEPARTMENT OF HEALTH & HUMAN SERVICES: Pulble Health Service: i Retedenioie Ss Seeaooe a Certificate of Exportabitity Section 802 - Name of Product(s) Attachment Page & of 11 (688035 Diamondback Bilary Slont 6.035, (885038 Diamondback Bilary Stont 5.038 (886015 Diamondback Bikar Stent. 60x15 1836018 Diemondbeck Bary Sient 6.0% 18 ‘886024 Diamondback Bilary Stent. 6.0% 24 ‘880030 Diamondback Bitary Stent. 6.0%30 ‘686033 Damondhack Bilary Slent 8 0x33 ‘887017 Diamondback Bary Sient 7.917 (987023 Diamondback Bikaty Stent 7.923 (687028 Digrnondback Biary Stent 7.028 {887030 Diamroncbsck Biliary Stent 7.930 (887033 Diamondback Bilary Sent 7.033 ‘750015195 Silene Peripheral Covered Stent 6.0% 15 *7$8025-135 Sieve Peripheral Covered Stont 6.0% 25 786005195 Siene Peripheral Covered Stent 6.095 1758050135 Stene Peripheral Covered Stent €.0.%50 "786070-135 Silene Perihera! Covered Stent 60X79 75TO15-195 Silene Peripheral Covered Stent 7.0% 15- 781025-795 Silene Peripheral Covered Stent 7.0% 25 75TO35+135 Silene Pwripheral Covered Stent 7.0%'35 757050195 Siena, Peripheral Covered Stent 7.0%50 ‘TSTO7O-T85 Silene Peripheral Covered Bien 7.0% 70 758016-135 Silone Periphoral Covered Stent 8.0%15: 7$8024-135 Silene Peripheral Covared Stent 8x24 ‘788022-136 Silane Periphora| Covered Stent 8.032 "758080-185 Silone Peripheral Covered Siont 8.050 ‘758070-195 Silene Peripharsi Covered Stent 8.070 '750015-(38 Stine Pesphoral Coverod Stont 9.015 730024-135 Silene Peripheral Covered Stont 8.024 7290832435 Silene Periheral Covered Stent 9.0x32 "759080-195 Silene Peripheral Covered Stent ©.0.x 50 '789070-4138 Siloce Poripharal Covered Stent 0x70 ‘75Y0015-135 Siene Peripheral Covered Stent 10.0% 15 ‘7510023-185 Silene Periaheral Covered Stent 10.0x23 ‘7810031-135 Stone Peripheral Covered Stent 100%3% 7510048-13 Silene Peripheral Covered Stont 10.048 ‘7810065-135 Stine Peripheral Covered Stent 10.065. 786015195 Diemocdoack Bilary Stant OW6.0x15. 760025195 Diamondback Bilary Stent OTWE.0 x25 788035-195 Diemondoack Bilary Siant CHWA.O% 35. #8050195 Diamondveck Bikary Stent. OTWE.0 x50. ‘785070495 Diamondloack Bilary Siect OTW0x70 ‘77018-4198 Diamondoeck Silay Stent OTW7.2¥ 15 787O25-195 Dietnondseck Bilary Stent OTW70%25 787098-195 Diamondback Bilaly Stent OTW7.03 35 “787050-199 Diamondback Bilary Stent OTW7.0% 50 787070-195 Diamondback Bilary Stont CTW 7.070. 7860154135 Diamondback Bilary Stent OTW8.0 x 15. ‘Ta8024-185 Diamondback Bitar Stem OTW80x 24 780032195 Diarsondack Bikary Stent OTW 8.0% 32 788080135 Diamondback Bly Stent OTW&0x80 ‘798070-135 Diamondback Bivary Sient OTW8.0x70 ‘769015-135 Diamondback Bilary Stent OTW9.0x 15, 7Te0024-136 Diemondack Bliary Sant OTWS.0 x 24 ‘780022-198 Diemondback Bilary Sient OTW 9.0 x32 '788050-135 Diamonsbeck Bilary Siont OTW9.0x 50 780070435 Diamondback Bilary Stont OTW0,0x70 7B10015-135 Dismisndack Bilary Stent OTW 10.0% 18 ‘Amjad Ahmad NOTARY PUBLIC Ml INNESOTA, sion Expir 98 January 31, 2019f° Y veeaxmamer or west THe HUMANSERUICES fe nara 3 3 Texan bepaannarn ‘toner aon ene Stee opia wo Doss Certificate No. 1756-3-2015 Certificate of Exportability Section 802 - Name of Product(s) Attachment Page 9 of 11 7810028-135 Diamencack Bay Stank OTW 00x29 7810001-135 Dienondback Biiay Sint OTW 10.0331 7310048-135 Diamoncack Bary Stnt OTW10.0x 4 810066-135 Diamondback Bilary Stet OTW 10.0x85 4411210 Ava PTCA Coronary Balioon Cathar 1253 10 ‘11215 Aniva PTCA Coronary Baioon Caer 1.253 15 411200 Arta PTCA Coronary Baloon Catheter 125.20 ‘441810 Awa PTCA Coronary Saloon Cater 1.8 10 “411515 Anva PTCA Coronary Baloon Cater 1.515 411820 ania PTCA CorenayBelloen Catto 1. 620 411590 Arve PTCA Coronary Baloo) Caster .5x0 442010 Arka PTCA Garonary Saloen Catheter 20x 10 412015 Ani PTCA Coronary Saloon Cater 20x 16 412020 ava PTCA Coxonay Balloon Catal 2.0320 4200 Ara PTOK Coronay Balloon Catholr 2.0 30 4122510 arvalPTCA Coronary atoon Cateter2 25. 10 #122815 Arriva PTCA Coronary Balloon Catheter 2.25% 15. 4122520 Arriva PTCA Coronary Balibon Catheter 2.25 20 apa aes 4122550 Aviva PTCA Coronary Balloon Catetr 225 x20 arenes 412510 Aria PTCA Coronary Balloon Cathtar2.6% 10 eo 412515 Arita PTCA Coronary Balloon Cathotor 26x 18. De ian 554s 412520 Arve PTCA Goronary Balloon Cater 25 20 412620 eatia PTCA Coronary Balloon Catelar 2.5 x90 413010 Anive PTCA Coronary Balloon Catety 2.0310 4419015 Arie PTCA Coronary Baloon Cathet 8.0 18 419020 artve PTCA Coronary BaloonCateter 3020 413025 Arrive PTCA Coronary Balloon Catheter 3.0.28 419030 Arve PTCA Coronary Balloon Gaeta 3.0330 413035 Ava PTOA Coronary Balloen Catotor 20% 38 14190510 Arve PTCA Coronary Baoan Caneter 3.25 «10 4132515 Av PTCA Coronary Bloor Caltater 3.26 x15. 46132820 Ave PTCA Coronary Bacon Cathal 9:25 x20, 4132590 Ara PTOA Geronay Batoon Catheter 5.25 x20 “433810 Ara PTCA Connery Bacon Cather 35x 10 413518 Amma PTCA Coronary Baloon Cathler.5.x 15 478520 Ava PTCA Govonay Baloo Catheter 35x20 418530 Arve PTCA Coronary Balen Cather 36120 413535 Arrive PTCA Coronary Balloon. Catheter 3.5 x35 “4537510 Ants PTCA Coronary Saloon Caoter 3:75 x10 4737885 Arve PTCA Coronary Balloon Cathet 3.7518 4187520 Arta PTCA Goronary Bacon Catheter 3.7620 4137530 Arva PTCA Goronary Bacon Catheter 3.7520 414010 iva PTCA Garena Balloon Catheter «010 414016 Artiva PTCA Coronary Balloon Catheter 4.0.15 416020 Aria PTCA Goronay Balloon Catheter 40% 20 414030 Arriva PTCA Coronary Balloon Catheter 4.0 x 30. 414040 Aa PTA Coronary Balloon Catiater 0 40 ‘4B10-Arva PTCA Coronary Balan Cathal 45 10 414515 Ava PTOA Coronary Baloo Calter 4 15 494520 Anna PTOA Garonary Baoon Catheter 4 5 x20 414530 Ava PTCA Coronary Boon Catheter 4.5x 30 416020 Arva PTCA CoronryBaloon Catheler 5 020 415030 Artiva PTCA Coronary Balloon Catheter 6.0 x 30. 215040 Ava PTCA Coronary Baloon Catala 6:0 40 436020 Arva PTCA Coronary Baton Catheter 8020 418020 Artie PTOA Coronary Saloon Catheter 60x 00 “418040 Arve PTCA Coronary Batoon Catheter 6x40 ‘417020 Aaiva PTCA Covossry Baloon Catheter 7020on £Y venacevanr on eau evan senvcs tone ( ‘aetna 10903 New empsbire Aver ‘iver Spring. MD 20889 Certificate No. 1786-3.2045 Cortficate of Exportability Section 802 - Name of Product(s) Atachment Page 40 of 44 417028 Aniva PTCA Goranary Balloon Catheter 7x25: 417030 Artie PTCA Coronary Balloon Catheter 70x 30 ‘417040 Aniva PTCA Coronary Balloon Catheter 7.0% 40 “417060 Aativa PTCA Coronary Balloon Catheter 7.0.60 442010 Aniva PTCA Coronary Balloon Catheter NC-2.0% 10 44205 Ania PTCA Coronary Balloon Gatheler NC-20% 15, 442020 Arriva PTCA Coronary Selloan Catheter NC 2.020 1442030 Arriva PTCA Coronary Balizon Catheter NC 20x20 442610 Antiva PTCA Corcnay Baloon Gathetse NC-25 x 10 442515 Aniva PTCA Coronaty Balloon Catheter NC 2.5 x 15 442520 Anrva PTCA Coronary Bason Catheter NC 2.520 4442530 Arrive PTCA Coronary Galloon Catheter NC 25x30 ‘442010 Aniva PTCA Coronary Balloon Catheter NC 3.0% 10 443015 Ants PTCA Coronary Balloon Catheter NC 3.0x 15 442020 Arriva PTCA Coronary Batloon Cather NC 3.0 x 20. 443090 Ariva PTCA Coronary Balloon Catheter NO 3.0 x 30 443510 Arve PTCA Coronary Baioon Cateier NC 3.5 10, 449518 Amva PTOA Coronary Belioon Catheter NC 3.5 x 15. 1443520 Aniva PTCA Coronary Balioon Cathet NC S.5 x 20 an ‘Amjad Ahmag 1449590 Arvo PTCA Coronary Balloon Catheter NC 3.5 x30 NOTARY PUBLIC ‘444010 Artes PTCA Coronary Balloon Catheter NC 4.0 10 eo MINNESOTA, 444015 Amv PTCA Coronary Balloon Catheter NC 4.015 a es ay 31,208 ‘444020 Arrwa PTCA Cotonary Batioon Catheter NC 4.0 20 444090 Arriva PTCA Coronary Balloon Catheter NC 4.030, 1644510 Ariva PTCA Coronary Saloon Catheter NC 45x 10 1444818 Artiva PTCA Coronary Balioon Catheter NC 45x15 -444520 Artiva PTCA Coronary Balloon Catheter NC 4.5 x20 1484520 Ariva PTCA Corenary Saioon Catheter NC 45x20 412010 Arrive PTGA Corona Balloon Catheter 2.0% 10 412016 Ariva PTCA Coronary Balloon Catheter 2.0 15 4412020 Ariva PTCA Coronary Baloon Catheter 2.0%'20 ‘412030 Ariva PTCA Coronary Balloon Catheter 20x30 412510 Artva PTGA Coronary Ballon Gather 25 »10 ‘412515 Aniva PTCA Coronary Baloon Catheier 2.8 x15 ‘412520 Ariva PTCA Coronary Balloon Catster 25 «20 412500 Ariva PTCA Coronary Balloon Cathetor 28x20 ‘439010 Aniva PTCA Coronary Balloon Catheter 3.0.x 10 ‘419018 Aria PTCA Coronary Balldon Catheter 3.0.x15 ‘489020 Arriva PTCA Coronary Balloon Cather 3.020 4419020 Arve PTCA Coronary Balloon Catheter 30x30 413810 Areva PTCA Coronary Balloon Cathoiar3,5 x10 ‘433815 Antva PTCA Coronary Balloon Cetnetor 3.5 x15 ‘418520 Artiva PTCA Coronary Balloon Gathoiar 38x20 ‘419590 Antva PTCA Coronary Baloon Caiheler 35 x30 414010 Arriva PTCA Coronary Ballon Cathwler 4.010 ‘484018 Artiva PTCA Coronary Baboon Catheter 4.0% 15. ‘414020 Aviva PTCA Coronary Balicon Catheter 4.0%20 1414090 Artiva PTCA Coronary Balloon Catheter 4.0 30 ‘414510 Artiva PTEA Coronary Balin Catheter 4 § x 10 414515 Aria PTCA Coronary Balloon Cetheior4 5x15, 414520 Arva PTCA Coronary Ballon Catheter 4.5320 414590 Aria PTCA Coronary Balloon Cameter 4.5 x30 ‘4520100150 Forie tong Balloon Catheter 2:0 x 400 Wi. 160em '4820180-150 Fortz Long Balloon Catheter 2.0. 150 Wl. 150cmn -4520200-180 Forte Long Balloor Cather 2.0 x 200 WL. 80cm -4825190-150 Forte Long Balloon Catheter2.§ x 100 WI. ‘50cm +4628180-150 Forte Long Balloon Gatheler 28 x 150'WL. 150cm ‘4630150-150 Fort:Lotg Balloon Catheter 3.0. 150.WH. 500moo Jy oeeaicrniener OF HAUT fe HUMAN SERVICES Plc Heath Service Se Certificate No. 1756-3-2015 Certificate of Exnortability Section 802 - Name of Product(s) Attachment Page t1 of 11 -4530200-150 Farte Long Balloon Catheter 3.0 x:200 Vi. 180em '4538100-180 Forte Long Balloon Cathater 2.6 x 100 VL 150em 4525150-150 Forte Long Balloon Catheter 3 $x 160 WL 160em -4595200-150 Forte Long Balloon Cathetor 3.5 x200 WL1S0em "4540100180 Forte Leng falison Catheter 4.0. 100 WL {506m 4S40150-150 Fone Long Balloon Catheter 4.0 x 1504. 180cr 4540200-150 Forte Long Balloon Gabieter 40x 200. 150cm -4545100-150 Forte Long Balloon Catheter 4.5 x 100 Wa. 10cm '4545180-150 Forte Long Balloon Catheter 48 x 150 Vi 1S0crn :4545200-150 Forte Long Balloon Cothetor 4.5 x 200 VL 40cm -4550100-150 Forte Long Balloon Catheter :0 x 100 Vit 70cm 4950180-160 Fors Long Balloon Catheter 6.0 x 160 Vi. dem 14855160-150 Forte Long Balloon Catheter 5.5 x 1604. ‘Sum 4855200-150 Forte Long Baloon Catheter 55x 200 WL 160m, “45801004150 Fodte Long Baloen Catheter 8.0.x 1D0WWL 180m -4880150-150 Forte Long Balloon Catheter 8.0.x 150M. 150cn -4560200-150 Foe ong Balloon Catheter 8.0 x200 V1. 180em '4885100-150 Forie Long Balloon Gatheter 6.5 100M. 150cm 4565150-150 Forte Long Batioon Catheter 65x 160 We. 100m '4885200-150 Forte Long Batloon Catheter 6.5 x 200 W4. 150em seeneeemnennne- ND OF PRODUCT LIST Gey Ana aa fie) sorntv rue BID canst EEOTA Fed nd Dg Ansan 10803 New Hamire Aero ‘Siver Spng, MD 20083,