DEPARTMENT OF HEALTH & HUMAN SERVICES 555 Public Healy Service Foland Drug Adminsirabon 10903 New Hampshire Avenue Siver Spring. MO 20099 Certificate No. 7368-9-2015 : ‘CERTIFICATE TO FOREIGN GOVERNMENT ~ In order to allow the importation of United States products into foreign countriés ; he 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 Manufacturer == MENTOR 5 (11 Pages) s a04f SKYWAY CIROLE NORTH IRVING, Tx USA 76038 ‘The product(s) described above (and the manufacturing/distribution site(s) which produces/distributes 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 at this time. The manufacturing plant(s) in which the product(s) is produced is subject to periodic inspections. The last such inspection showed that the plant(s), at that time, appeared to be in substantial compliance with current good manufacturing practice requirements for the product(s) listed above. Carl Fischer, Ph.D. Director Division of Intemational Compliance Operations Office of Compliance Center for Devices and Radi logical Health ate is valid from September 17, 2015 to September 16, 2017.DEPARTMENT OF HEALTH & HUMAN SERVICES: Publ Healh Service : s Food and Drug Adnan * ‘8 New Kamps Avene me aS : © iver Sng, MD 20988 Certificate No, 7389-9-2015 Cortieate te Foreign Government - Name of Product(s} Attachment Pago 1 of 1{ Name of Manufacturer MENTOR 2041 SKYWAY CIRCLE NORTH IRVING, TX USA 75038 s Se Name of Product(s) ‘Smooth Round Spectrum Post Operative Aajutabe Saline Breast Implant Catalog No. Size 350-1810 125.0 3 350.1420 178.60 350-1430 225.ce 350-1440 27500 350-1460 $2500 350-1460 375 ce 350-1470. 428 ce 350-1480. 475.cc 350-1485. 625.cc : 360-1490. 675 cc" ‘Smooth Round Maderate Profile Saline Breast Implant with Diaphragm Valve Catalog No." Size 350-1610 | 42506 350-1815 1506 350-1620 175.ce 350-1625 200¢e 350-1630 228.0 350-1635 250.ce 350-1640 278 350-1645 300co 350-1650 3250 350-1655. 350.6 350-1850 375.0 360-1870 428.cc 350-1680 475.cc 390-1685 $280 350-1890. 75.cc 350-1695. 625.60. 380-1897 700.ce ‘Smooth Round Moderate Plus Profle Saline Breast Implant with Diaphragm Valve Catalog No. Size 3502175 175ce 350-2200 -200.ce 350-2225 225.c0 350-2250. 2500 350-2275: 78te 350-2300 -300¢e 350-2825. - 3250 350-2350. 350ce- 360-2975 <-a76ice 350-2400 400.0. 350-2425 428 ce 350-2450. 450.66 350.2475. 47500 350-2500. s00ce 350-2550 §50.ce 360-2600. 600 ce. 350-2650 650ceDEPARTMENT OF HEALTH & HUMAN SERVICE Pubic Health Service Food and Drug Administration "a 10903 New Hampshire Avenue “ ‘iver Spring, MO 20993, Certificate No. 7389-9-2015 Certificate to Foreign Government - Name of Product(s) Attachment Page 2 of 11, 350-2700 700 ce 350-2780 750co 350-2800 800 ce ‘Smooth Round High Profile Saline Breast Implant with Diaphragm Valve Catalog No. Size 3503170 170e5 350-3180 190ce 390210 2102 380.3290. -230ce 360.3250 250.0 3603270 270.0 3603290 290ce 350-3310 310¢c 350-3330 330.ce 350-3380 _380.cc 350-3420 4200 350-3460 480 co 350-3500 500 co 350-3560 560 cc 350.3630. 630.ce. Siltex™ Spectrum® Post-Operatively Adjustable Saline Breast Implant Catalog No. Size 354-2610M. 125 cc 354-2820M 175.0 354-2430M 225 co 354.2440M 27500 354-2450M 3250 354-2460M 3750 354-2470M 425¢c 354.2480M. 475 oc 354.2511 275 06 354-2512 350ce 354.2513 450ce 354.2514 §50ce 354.2515 _650ce 360-DOMPK Injection Domes with Stainless Steel & True-Lock Connection Systems Sitex™ Round Moderate Profle Saline Breast Implant with Diaphragm Valve Catalog No. Size 354.2610 12500 354.2615 180.0 354-2620 175.0 354-2625 200ce 354-2630 225. 354-2685 250.0 364.2640 275.0 354.2645 300¢e 364.2680 828ce 354.2655 350. 354-2660. 375.ce 354-2670 425.ce, 354-2680 475.06 Sitex™ Contour Profia™ Saline Breast implant with Diaphragm Valve Catalog No. Size 3642711 27500DEPARTMENT OF HEALTH & HUMAN SERVICES Public Hoatth Service Food and Drug Administration 10903 New Harnpstire Avenue ‘iver Spring, MD 20993, Certificate No. 7389-9-2015 Certificate to Foreign Government - Name of Product(s) Attachment Page 3 of 11, 35427123500 354.2713 4500 354.2714 550ce 354.2715 850ce 354.2910 175¢0 354.2911 2250 354.2912 275¢0 354-2913. 350ce 354.2914 42500 354.2918 5250 600975-001 Mentor Diaphragm Valve - Fil Tube ‘Smooth Round Moderate Plus Profle Gel-Filled Breast Implants Catalog No. Size 350100186 100.co 350125160 _125.cc 350-160186 150 co 360-4751BC 1750 350-20018C - 200 ce 380225186 225 ce 350-2501BC 250ce 350275186 275¢c 350-30018C 300 ce 350-32518C 325 cc 350-35018C 350cc 350-37518C 37500 350-4016 400.co 350:42518C 425 .ce 350-45018C 450 ce 360-47518C 475 ce 360-50018C 500 ce 350525186 525cc 350-55018C - 550.cc 350-57518C 5750 3§0-60018C 800 co 350-6501BC 650.cc 350-70018C_700ce 350-75018C 760ce 350-90018C 800ce ‘Smooth Round High Profile Gel-Filed Breast Implants, Catalog No. Size 350-12548C 1250 350-15048C 150.co 350175486 1750 350-20048C 200.cc 350-22548C 22500 350-25048C © 250.cc 350-27548C 275.ce 350-20048C 300ce 350-32548C 325cc 350350486. 35006 350375486 375¢c 380-4004BC 400 ce 350-4254BC 425 ec 350-45048C 450.ce 350475480 475.0 350-50048C 500 coYe, DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Servico Food and Drug Adminis ration 10803 New Hampshire Avenue Siver Spring, MO 20903 Cortificate No. 7389--2015 Certificate to Foreign Government - Namo of Product(s) Attachment Page 4 of 11, 350-55048C '350-60048C. 350-8504BC 360-70048C. 360-7504BC ‘350-0048¢ 550 cc 6006 506 700ce 780 .¢ 200 c¢ ‘Smooth Round Moderate Profile Gel-Filed Breast Implanis| Catalog No. 380-7008 350-7125 360-715086 360-71758C '350-72008C 350-72258C 350-72508C 350-72758C '360-73008C 360-73258C '380-7350BC 350-73758C '350-74008¢ 350-74508C '350-75008C 350-7508 '350-76008C 350-770080 350-78008C ‘Size 100 ce 128 ce 450.00 175 cc 200 ce 225 ce 20 ce 278 ce 300 ec 32560 35006 375 eo 400 c° 450 ce 500 ce 550 cc 600 ce 700 ec 1800 ce ‘Smooth Round Moderate Classic Profile Gel-Filed Breast Implants Catalog No. 350-7130MC_ 350-7150MC 360-7170MC '350-7190MC 350-7215MC 350.7235MC 350-7255MC 350-7275MC '350-7300Me 350-7320MC_ 350-7340. 350-7360MC 350-7385MIC 350-7405MC 350-7425MC 350-7445MIG 350-7470MO 350-7490MC 350-7510MC '350-7555MC 350-7595MC 350-7640MC '350-7680MC 350-7750MC '350-7800MC ‘Smooth Round Ultra High Profile Silicone Gel-Filed Breast Implant ‘Size 130 ¢¢ 160 cc 170ce 1900 215ce 235.c0 285 co 275c0 3006 320c0 340 co 360 00 385 cc 405 co 425 cc 448 cc 47060 490.cc 51000 555 00 595 c¢ 40 ce 80 ce 750 ce 800 ceDEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Servieo Food and Drug Administration 10903 New Hampshire Avenue Siver Spring, MO 20883 Certificate No. 7389-9-2015 Certificate to Foreign Government - Name of Product(s) Attachment Page § of 11 Catalog No. 350.5135 360-516086 350518586. 350-5215 350-524080 350-52708C 350-52958C 350-5208 380-53508C '350-53758C 35054008 350-54308C 380-5455BC. '350-5408C 360.55358C. 360-55908C ‘Size 13500 160 ce 185 cc 218ce 2a0 ec 2100 295 ce 320.60 380 co 375 66 400 ce 430 ce 455 cc 480 ce 535 co 590 oc Silex"! Round Moderate Plus Profile Gel-Filled Breast Implants Catalog No. 354-1001 354-1251 354-1501 354.1751 354-2001 354.2251 354-2501 354.2751 354-2001 354-2251 354.2501 354-2754 354-4001 3544251 354-4501 354.4751 354-5001, 354-5251 354-5507 354.5751 354-6001 354-6501 354-7001 354-7501 364-8001 Sitex™ Round Moderate Profile Gel-Filed Breast Implants Size Catalog No, 384-1007 354-1257 354-1507 354-1787 354-2007 354-2257 354-2507 354.2757 354-2007 354-3257 Size 100°c6 125 ce 180 ce 178 ce 200 ec 22500 250 cc 275 00 300 oe 525 00 360 ce 375 cc 400 ¢¢ 425.00 450 ce 475 00 500 ce 525 c¢ 550 ce 875 ce 600 ce 1650 .cc 700 ce 750.60 800 ce 100 ce 12800 150ce 175.06 200 cc 225 cc 280 co 275 ec 300.ce 32500G Esene cena ann tin sic 5% Food and Onug Administration = ‘croton ange howe Sherr. oe Cortificate No. 7389-9-2015 Certificate to Foreign Government - Name of Product(s) Attachment Page 6 of 11 354.3507 3500 354.3757 375.c0 3544007 400.¢e 354-4507 450.6e 354-5007 S00ce 354-5507 550.ce 364.6007 - 600 ce 354-7007 700¢e 354-8007. 800.co Silex" Round High Profile Gel-Filed Breast Implants Catalog No. Size 354-4125 12500 354-4150 18060 3544175 175¢c 354-4200 200.ee 3544225 228.c¢ 354.4250 250.ce 354-4275 275 co 354-4300 - 300c¢ 350-4325. 325.00 354-4350 350.¢c 354.4375 375.60 354-4000 -400.ce 3644425 4250 354-4450 450c0. 354-4075 47500 354-4500 500.ce 354-4550 §50.ce 354-4600 600.ce 354-4650 650.cc 354-4700 700.ce 354-4750 750ce 354-4800 800.00 Sitex™ Round Moderate Classic Profile Gel-Filled Breast implants Catalog No. Size 3541307MC 120 ee 354-1507MC. 160 ¢¢ 354¢1707MC170ce 354-1907MC 190 cc 354-2157MC 215 00 354-2357MC 235 co 354-2557MC. 25500, 364.2757MC_275ce 3543007MC 300 ce 364-3207MC 320 ee 3543407MC 340 ce 354-3607MC 360 ec 354-3857MC 385 cc 354-4057MC_ 405 ce 354-4257MC 425 o¢ 354-4457MC 445 cc 354.4707MG 470.ce 354-4907MC 490 ce 354.5107MC 510cc 354-5557MC 555.co 354-5957MC 595.ccGennes aman sees pat ih Son i Food ana Org Aamiistton {0005 New Hanan fence Siva ong, MO 20082 Certificate No. 7389-9-2015 Certificate to Foreign Government - Name of Product(s) Attachment Page 7 of 11 354-8407M0. 640.00 354-8807MC 680.co 354-7507MC_.750.ce 354-8007MC 800.ce Siex™ Round Ulra High Profle Silicone Gel-Filed Breast Implant Catalog No. Size 354.5135 135¢¢ 354.5160 160.00 354.5185. 185¢0 354-5215 2180 345-5240 2400 3545270 -27D¢c 3645205 29500 354-5320 -320.cc 354-5350 350.ce 354-5375 378.ce 354-5400 400¢0 354.5490 “430ce 354-5455 455.00 354.5480 480 ce 354-5535 635 ce Single Use Saline Breast implant Sizer - Round Moderate Profile Catalog No. Size 351-125SZ 125.0 35147582 1750 2351-22582 225¢¢ 35127582 275cc 351-2582. 325¢c 351-7582 375¢c 35142582425 cc 35147582475 cc Single Use Saline Breast Implant Sizer - Contour Profile Catalog No. Size 351-07118Z 275.0 351-071282 350ce 351-071382 450 ce 351071482 550 ce S51.07158Z 650.0 Single Use Saline Breast implant Sizer- Round, Moderate Plus Profile Catalog No. Size 351-21758Z 175 00 351-22008Z 200 cc 351-222582 22500 351-225082 250 ce 351227582275 cc 381-290082 "300 cc 351-292582 _325cc 351-286082 350 oc 351-237882 375 00 351-24008Z 400 oc 351-24258Z 425 ce 351-245082 450 ce 351-247582._ 475 cc 351-250082 500 ccDEPARTMENT OF HEALTH & HUMAN SERVICES ube Health Service Food and Drig Administration S 10903 New Hampshire Avenue = ‘iver Spring, MO 20999, Certificate No. 7389-9-2015 Certificate to Foreign Government - Name of Product(s) Attachment Page 8 of 11 351-255082 550 .ce 351-260082 _600¢e. 351-265082 650.00 351-270082 700c¢ 351-27508Z 750.c0 351-2800SZ 800 co Single Use Saline Breast Implant Sizer - Round, High Profle Catalog No. Size 351-319082 190 ce 351-323082 230 ce 351-827082 270 cc 351-220082 290 cc 351-82108Z 3100 351-33208Z 330cc 381-3380SZ 380.cc 351-342082 _ 420.co 351-3500SZ500.ce 31-36308Z 630.ce MemoryGel Resterlizable Gel Sizer Moderste Classic Profile Catalog No. Size RSZ-7130MCS 130 0 RSZ-7150MCS 180 cc RSZ-7170MCS. 170 ce RSZ-7190MCS 190 oc RSZT21EMCS 215 ce RSZ-7235MCS 225.cc RSZ-T255MCS__ 255 cc RSZ-7275MCS 275 cc RSZ-7300MCS 300 co RSZ-7320MCS. 320 cc RSZ-7340MCS 340 co RSZ-7360MCS 360 co RSZ7385MCS 385.c0 RSZ-7405MCS. 405 co RSZ-7425MCS 425 cc RSZ7445MCS. 445 cc RSZ-7470MCS _470.ce RSZ-7490MCS 490 ce RSZ7S10MCS 510 cc RSZ7SS5MCS 855 ec RSZ-75OSMCS 595 ce RSZ-7640MCS 640 ct RSZ-76B80MCS 680 cc RSZ-7750MCGS 750 co RSZ-7800MCS 800 co MemocyGel Resterilzable Ge! Sizer High Profle Catalog No. Size RSZ-12545 125 cc RSZ-15045. 1500 RSZ-17545. 175 cc RSZ-20045 200 cc RSZ22543 225.cc RSZ-25048 250 ec RSZ27548. 275 c¢ RSZ-30048 300 cefy DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service: C Teco noon he 10903 New Hampshire Avenue ‘ver Spring, MO 20999 Certificate No. 7389-9-2015 Certificate to Foreign Government - Name of Product(s) Attachment Page 9 of 11 RSZ-32548 925 ec RSZ-35048 _350.¢° RSZ-37548 _375.cc RSZ-40048 400 ec RSZ-4254S 425 co RSZ-45048 450.ce RSZ-47545 47562 RSZ-50048 500. ce RSZ-55045 . 550 ce RSZ-60048 6000 RSZ-85048 650 co RSZ-70048 — 700 ce RSZ-75048 780ce RSZ-80048 800 co MemoryGel Resterizable Gel Sizer Ulra High Profie Catalog No. Size RSZ51358 195 ce RSZ-51605 160 ce RSZ-51855 185.00 RSZ-52158. 21500 RSZ-5240S 240 co RSZ-5270S 270 ce RSZ5295S 295 ce RSZ-53208. 320 co RSZ-5350S 350 ce RSZS375S 375 co RSZ-5400S 40000 RSZ-5430S 430 ce RSZ-5455S. 485 cc RSZ-54808 480 cc RSZ-55355 535 cc RSZ-5590S 590 co Port Detector/Locator, Aseptic Flu Transfer System Catalog No, 350.4402 _Centerscope® Magnetic Detection Device 350-8400 Aseptic Fd Transfer Sets ‘Smooth Tissue Expander with Remote Injection Dome Catalog No. Size 350-4301M 100.¢c 350-4302M 250 ce 360-4303M 400 cc 350-4309M 50ce 350-4310M- 850 ce 350-4311M 700 ce 350-4304M_700.ce 350-4305M 400 ce 350-4306M 1000 ce 350-4307M — §50.ce 350-4308M 850 ce 350-4312M —50.ce, 350-4313M —100.ce 360-4314M_ 200.0 350-4315M_ 300.0 350-4316M 400 co 3804317M —500.coDEPARTMENT OF HEALTH & HUMAN SERVICES Pubic Heath Service Food and Drug Administration 10903 New Hampstire avenue Siver Spring, MO 20983 Certificate No. 7389-9-2015 Certificate to Foreign Government - Name of Product(s) Attachment Page 10 of 14 350-5301M 2.60 350-5302M — 50.ce 350-5303M —75ce 350-5304 150.ce 350-5305M — 250.ce 350-5306M 125.60 Siltex™ Contour Proflle® Breast Tissue Expander with Inlegral Injection Site Catalog No. Size 354-6111 250ce 3546112 350ce 3546113 4500 354.6114 550.c0 3546115 650.ce 354.6116 750.ce 354.6211 278¢e 354.6212 350ce 354-6213 450.e 354-6214 850.00 354.6215 660ce 384-6216 800ce 354.6311 250.0 354.6311 250.ce 354.6312 3500 354.6313. 450.cc 354.6314 550.0 354.6315 650.ce 354-6316. 750ce 354.6317 850.ce (CPX3™ Sitex™ Contour Profile® Breast Tissue Expander with Suturing Tabs Catalog No. Size 3547111. 25060 3547112 380.0 354.7113 450.0 3547118 $50.0 354-7115 650.ce 354-7116 750ce 3547211 2750 354-7212 36060 354-7213 450.ce 354-7214 550.0 354-7215 650.ce 354-7218 800.ce 3547311 250ce 3547312 350.ce 354-7313 450.0 354-7314 5500 354-7315 65000 354-7316 750ce 354-7317 850ce (CPX™4 Breast Tissue Expander, Textured, Integral Injection Dome Catalog No. Size 384.8111 250.6 354.8112 350.ce 3548113 450.0 3548114 850ceony if DEPARTMENT OF HEALTH & HUMAN SERVICES Palle Heath Serie Food and Oro Administration “he 10803 New Hampstire Avenue ae ‘Sliver Spring, MD 20883. Certificate No, 7389-9-2015 Certificate to Foreign Government - Name of Product(s) Attachment Page 11 of 11 354.8115 650.cc 354.8116 750.cc 3548211 275cc 354.8212 -350.c0 3548213 450.ce 3548214 550.ce 354-8215 650.ce 354-8216 800ce. 3548311 2500 3648312 3500 3540313 450ce 3548314 §50cc 3548315 650cc 3548316 750ce 354.8317 850co 3540111 354.9112 354.9113 354.0114 354.9115 354.9116 354-9211 354.9212 354.9213 354.9214 354-9215 354-9216 354.8311 356-9312 354.9313 354.9314 354.9915 354-9316 354.9317