EVEROLIMUS ELUTING COBALT CHROMIUM CORONARY STENT SYSTEM - India CDSCO Medical Device Registration

EVEROLIMUS ELUTING COBALT CHROMIUM CORONARY STENT SYSTEM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000321_95e0f23e21b932861bb1c4d15bd79bd4_0981660b56a0034c6f48e359dd34ea80. This device is marketed under the brand name SAVIOUR/TRACK. The license holder is Relisys Medical Device Limited, and it is classified as Device Class Class D. The approving authority is CDSCO, Zonal office, Hyderabad.

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CDSCO Registered

Class Class D

EVEROLIMUS ELUTING COBALT CHROMIUM CORONARY STENT SYSTEM

UID: MFG/MD/2022/000321_95e0f23e21b932861bb1c4d15bd79bd4_0981660b56a0034c6f48e359dd34ea80

Brand Name

SAVIOUR/TRACK

License Holder

Relisys Medical Device Limited

Device Class

Class D

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

The Everolimus Eluting Cobalt Chromium Coronary Stent System is indicated for improving luminal diameter and reducing restenosis for the treatment of de novo lesions in native coronary arteries. Everolimus Eluting Cobalt Chromium Coronary Stent System is also indicated for treatment of abrupt of threatened closure in patients with failed interventional therapy. The drug coating is intended to inhibit restenosis