Thoracic Stent Graft System - India CDSCO Medical Device Registration

Thoracic Stent Graft System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000050_fa56b66f5e3714c9dca3685686daa89a_cf5c7c25736c227df4e85b8b23665671. 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

Thoracic Stent Graft System

UID: IMP/MD/2019/000050_fa56b66f5e3714c9dca3685686daa89a_cf5c7c25736c227df4e85b8b23665671

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 Valiant Navion Thoracic Stent Graft System is indicated for treatment of diseases of the descending thoracic aorta, including, but not limited to, aneurysms, dissections, and blunt traumatic aortic injuries (Onyx TruCor Zotarolimus-Eluting Coronary Stent System). The Valiant Navion thoracic stent graft is indicated for exclusion of the aneurysm, the false lumen, or site of rupture, and the restoration of blood flow through the stent graft lumen. The device is intended for use in patients who are candidates for conventional surgical repair, and in patients who are not candidates for conventional surgical repair due to pre-existing risk factors