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Non-Sterile Biodegradable Polymer based Sirolimus Eluting Coronary Stent System - India CDSCO Medical Device Registration

Non-Sterile Biodegradable Polymer based Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000008_0c717bcc58815186db23a40412a494a6_9a52237bc67a6ae9e20286d528945134. This device is marketed under the brand name Vestasync Sirolimus Eluting Coronary Stent System. The license holder is PURPLE MICROPORT CARDIOVASCULAR PRIVATE LIMITED, 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
Non-Sterile Biodegradable Polymer based Sirolimus Eluting Coronary Stent System
UID: MFG/MD/2019/000008_0c717bcc58815186db23a40412a494a6_9a52237bc67a6ae9e20286d528945134

Brand Name

Vestasync Sirolimus Eluting Coronary Stent System

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Biodegradable Polymer based Sirolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease in de novo coronary artery lesion in native coronary arteries with a reference vessel diameter of 2.00 mm to 4.50 mm in patients eligible for percutaneous Transluminal Coronary Angioplasty (Vestasync Sirolimus Eluting Coronary Stent System)

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