Endovascular Graft - India CDSCO Medical Device Registration

Endovascular Graft is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000050_66fb71dd05c3b79a160efee02acf230b_164f7f4c8864ba2511b6fb42627707f0. 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

Endovascular Graft

UID: IMP/MD/2019/000050_66fb71dd05c3b79a160efee02acf230b_164f7f4c8864ba2511b6fb42627707f0

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 Thoracic Stent Graft with the Captivia Delivery System is indicated for treatment of diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The Valiant Thoracic Stent Graft is indicated for exclusion of the aneurysm, the false lumen or site of rupture and 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