Sirolimus Eluting Biodegradable Polymer Stent System - India CDSCO Medical Device Registration

Sirolimus Eluting Biodegradable Polymer Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID G/28/1396_64a199cc5c22cb59a574e8af06fbfd15_dbb1a817ca02bcde8d9673b247981a23. This device is marketed under the brand name Devoir, Vanquisher. The license holder is Envision Scientific Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

Sirolimus Eluting Biodegradable Polymer Stent System

UID: G/28/1396_64a199cc5c22cb59a574e8af06fbfd15_dbb1a817ca02bcde8d9673b247981a23

Brand Name

Devoir, Vanquisher

License Holder

Envision Scientific Pvt. Ltd.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

• Abrax CoCr is indicated for treatment of patients with stenosis in Coronary Arteries and for improving and maintaining the coronary luminal diameter in patients including those with symptomatic ischemic disease, stable angina, and unstable angina due to lesions of length ≤ 40 mm in native coronary arteries with a reference diameter from 2.25mm to 4.00mm. • An elective implantation and in the treatment of acute or threatened closure associated with a coronary intervention and in patients undergoing Primary PCI (Devoir, Vanquisher) in patients with Acute Myocardial Infarction. Also, it is indicated in patients with diabetes mellitus and lesions in Coronary Arteries with diffuse proliferative disease

Class D

Brand: Focus np, Abluminus np, Cynosure

Class D