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CDSCO UID IMP/MD/2019/000419_b101711203cae2fa44c17ced25f85b10_4cea8b8cc3659b535884cee8b00728f7

PTA Balloon Catheter

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·Device Class Class B·India CDSCO·Brand: Fortrex™ HP PTA Balloon Catheter
Registration details
UID
IMP/MD/2019/000419_b101711203cae2fa44c17ced25f85b10_4cea8b8cc3659b535884cee8b00728f7
Device class
Class B
Brand name
Fortrex™ HP PTA Balloon Catheter
License holder
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
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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About this record

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 Fortrex™ 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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