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CDSCO UID IMP/MD/2018/000172_89af8a209a7efa7be5dcf54637bbdf24_a6275cde0ecd61378ebe0311ee06ec77

Balloon Expandable Peripheral Stent 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·Device Class Class C·India CDSCO·Brand: Everflex Self Expanding Peripheral stent with Entrust delivery system
Registration details
UID
IMP/MD/2018/000172_89af8a209a7efa7be5dcf54637bbdf24_a6275cde0ecd61378ebe0311ee06ec77
Device class
Class C
Brand name
Everflex Self Expanding Peripheral stent with Entrust delivery system
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
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: • Common and external iliac, subclavian • Renal Stenting is intended to improve and maintain artery luminal diameter. Biliary – The Visi-Pro Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree
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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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About this record

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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