Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter - India CDSCO Medical Device Registration

Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000140_f38a95670092cb334e9bffcd87e3baef_d1cd88144ec68dcb398a3412d9539baf. This device is marketed under the brand name PALMAZ GENESIS®. The license holder is Cardinal Health Medical Products India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter

UID: IMP/MD/2022/000140_f38a95670092cb334e9bffcd87e3baef_d1cd88144ec68dcb398a3412d9539baf

Brand Name

PALMAZ GENESIS®

License Holder

Cardinal Health Medical Products India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Cordis AVIATOR™ PLUS PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.