Drug Eluting stent - India CDSCO Medical Device Registration

Drug Eluting stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000050_fa2d22a986c236d5da466b1e8d914037_dca4407dba914ae3ec5b7fe09e8fd0e3. 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

Drug Eluting stent

UID: IMP/MD/2019/000050_fa2d22a986c236d5da466b1e8d914037_dca4407dba914ae3ec5b7fe09e8fd0e3

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 Endeavor Resolute Zotarolimus Eluting Coronary Stent system is intended for use in patients eligible for Percutaneous Transluminal Coronary Angioplasty (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) with a reference vessel diameter of 2.25 mm to 4.0 mm. Endeavor Resolute stent is intended to improve coronary luminal diameters as an adjunct to coronary interventions and reduce restenosis. The stents are intended as permanently implanted devices.