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CDSCO UID IMP/MD/2018/000172_af47846a1e9142389a4b5a4c07185858_bd646c6a74d1d1e45e07b6a8a21c3a41

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_af47846a1e9142389a4b5a4c07185858_bd646c6a74d1d1e45e07b6a8a21c3a41
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
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 for restenosis following PTA in the common iliac, external iliac, superficial femoral, proximal popliteal or subclavian arteries. Stenting is intended to improve and maintain artery luminal diameter
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About this record

Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000172_af47846a1e9142389a4b5a4c07185858_bd646c6a74d1d1e45e07b6a8a21c3a41. 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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