Sirolimus Coated PTA Balloon Catheter(Xtreme Touch Neo, Magic Touch PTA) - India CDSCO Medical Device Registration

Sirolimus Coated PTA Balloon Catheter(Xtreme Touch Neo, Magic Touch PTA) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000235_17e41ad12c1456d9d57cfc506b8707c1_95c081bc7d6e8c2d15adb9fa18853402. This device is marketed under the brand name First brand. The license holder is Envision Scientific Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Sirolimus Coated PTA Balloon Catheter(Xtreme Touch Neo, Magic Touch PTA)

UID: MFG/MD/2020/000235_17e41ad12c1456d9d57cfc506b8707c1_95c081bc7d6e8c2d15adb9fa18853402

Brand Name

First brand

License Holder

Envision Scientific Pvt. Ltd.

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Sirolimus Coated PTA Balloon Catheter is single usable, invasive, non‐implantable device intended to use for treatment of de novo, restenotic lesions in lower extremity vascular disease (First brand) and renal arteries.

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Brand: Focus np, Abluminus np, Cynosure

Class D