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CDSCO UID IMP/MD/2018/000172_4e04bf06413147b00062e5ec2e4ce333_e38c3a10690ea0072b805098b256ba2d

Self-Expanding 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_4e04bf06413147b00062e5ec2e4ce333_e38c3a10690ea0072b805098b256ba2d
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
The 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 for restenosis, following PTA in the common iliac, external iliac, or subclavian arteries. Stenting is intended to improve and maintain artery luminal diameter. Carotid: The Protégé RX is intended for the treatment of stenosis of the common carotid artery (Everflex Self Expanding Peripheral stent with Entrust delivery system), internal carotid artery (Everflex Self Expanding Peripheral stent with Entrust delivery system) and carotid bifurcation
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About this record

Self-Expanding Peripheral Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000172_4e04bf06413147b00062e5ec2e4ce333_e38c3a10690ea0072b805098b256ba2d. 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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