Endovascular graft - India CDSCO Medical Device Registration

Endovascular graft is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000050_fe17f951fff1f9e18ba90494083de3b3_7ad38a008c9363301e4d0b9c13d8407d. This device is marketed under the brand name Onyx TruCor Zotarolimus-Eluting Coronary Stent System. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Endovascular graft

UID: IMP/MD/2019/000050_fe17f951fff1f9e18ba90494083de3b3_7ad38a008c9363301e4d0b9c13d8407d

Brand Name

Onyx TruCor Zotarolimus-Eluting Coronary Stent System

License Holder

India Medtronic Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Endurant II/Endurant IIs stent graft system is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients with the following characteristics: ? adequate iliac or femoral access vessel morphology that is compatible with ? vascular access techniques, devices or accessories ? proximal neck length of ?10 mm with insignificant calcification, or insignificant ? thrombus with ?60° infrarenal and ?45° suprarenal angulation and a vessel ? diameter approximately 10% to 20% smaller than the labeled ? Endurant II/Endurant IIs stent graft diameter. ? proximal neck length of ?15 mm with insignificant calcification, or insignificant ? thrombus with ?75° infrarenal and ?60° suprarenal angulation and a vessel ? diameter approximately 10% to 20% smaller than the labeled Endurant II/Endurant IIs stent graft diameter. ? distal fixation length of ?15 mm ? aortic neck diameters with a range of 19 to 32 mm ? iliac diameters with a range of 8 to 25 mm ? morphology suitable for aneurysm repair ? one of the following: o aneurysm diameter >5 cm o aneurysm diameter of 4 to 5 cm, which has also increased in size by 0.5 cm o in the last 6 months o aneurysm that is at least 1.5 times the diameter of the normal infrarenal o aorta