Paclitaxel Eluting PTCA Balloon Catheter - India CDSCO Medical Device Registration

Paclitaxel Eluting PTCA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000050_8fd25b47986d05eb7960a26acff94c4b_b32f94f59d38d5bb673ff3fed2cf6bfc. 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

Paclitaxel Eluting PTCA Balloon Catheter

UID: IMP/MD/2019/000050_8fd25b47986d05eb7960a26acff94c4b_b32f94f59d38d5bb673ff3fed2cf6bfc

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 IN. PACT Falcon is intended to be used in the native coronary arteries. It is indicated for the dilatation of the stenosis portions, including total occlusions and acute myocardial infarction. It is also indicated for the post dilatation of stents