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Balloon Expandable Peripheral Stent System - India CDSCO Medical Device Registration

Balloon Expandable Peripheral Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000172_89af8a209a7efa7be5dcf54637bbdf24_a6275cde0ecd61378ebe0311ee06ec77. This device is marketed under the brand name Everflex Self Expanding Peripheral stent with Entrust delivery system. 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 C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Balloon Expandable Peripheral Stent System
UID: IMP/MD/2018/000172_89af8a209a7efa7be5dcf54637bbdf24_a6275cde0ecd61378ebe0311ee06ec77

Brand Name

Everflex Self Expanding Peripheral stent with Entrust delivery system

Device Class

Class C

Approving Authority

CDSCO

Product Information

Peripheral - The Visi-Pro Stent is indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (Everflex Self Expanding Peripheral stent with Entrust delivery system), or lesions believed to be at high risk of stenosis following PTA in the following arteries: โ€ข Common and external iliac, subclavian โ€ข Renal Stenting is intended to improve and maintain artery luminal diameter. Biliary โ€“ The Visi-Pro Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree

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Stent System

Brand: Everflex Self Expanding Peripheral stent with Entrust delivery system

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

Class C

Balloon-Expandable Peripheral Stent System

Brand: Everflex Self Expanding Peripheral stent with Entrust delivery system

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

Class C

Self-Expanding Peripheral Stent System

Brand: Everflex Self Expanding Peripheral stent with Entrust delivery system

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

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Self-Expanding Peripheral Stent System

Brand: Everflex Self Expanding Peripheral stent with Entrust delivery system

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

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Self-Expanding Peripheral Stent System

Brand: Everflex Self Expanding Peripheral stent with Entrust delivery system

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

Class C