~TERUMO ‘Terumo Europe NV Researchpark Hzasrode 1520, Interleuventaan 40 3001 Leuven, Belgium Tels +32 16 38 12 11 Fax: +32 16 40.02.49 ‘wsterumo-europe.com 8/7/2020 Declaration Letter We, TERUMO EUROPE N.V., Interleuvenlaan 40, 3001 Leuven, being the legal manufacturer of the Ultimaster ‘Tansei sirolimus eluting coronary stent system, hereby confirm that based on the equivalency of the Ultimaster Tansei stent system with the Ultimaster stent system, the extensive clinical evidence generated for Ultimaster is fully applicable for the Ultimaster Tansei stent system. Equivalency has been demonstrated considering its clinical, technical and biological characteristics which has been fully endorsed by our notified body MedCert (Zertifizierungs- und Priifungsgesellschaft flir die Medizin GmbH, Germany, N°0482), The sirolmus eluting stent of the Ultimaster Tansei stent system is identical to the stent of the Ultimaster stent system. The delivery system of the Ultimaster delivery system is slightly modified compared to the Ultimaster delivery system enhancing pushability and hence enhancing stent deliverability to the lesions. ‘Yours faithfully For and behalf of TERUMO EUROPE N.V., a Ariane Vanclée Regulatory Affairs Specialist, ‘Terumo Europe N.V. Taro BS DO BE ERE VAT VBE DAE TT