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PTA Balloon Catheter - India CDSCO Medical Device Registration

PTA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000419_b101711203cae2fa44c17ced25f85b10_4cea8b8cc3659b535884cee8b00728f7. This device is marketed under the brand name Fortrexโ„ข HP PTA Balloon Catheter. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
PTA Balloon Catheter
UID: IMP/MD/2019/000419_b101711203cae2fa44c17ced25f85b10_4cea8b8cc3659b535884cee8b00728f7

Brand Name

Fortrexโ„ข HP PTA Balloon Catheter

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Fortrex HP PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

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