Stent System - India CDSCO Medical Device Registration

Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000129_af47846a1e9142389a4b5a4c07185858_e3097f33b12a47dbd606b7c49ce662d8. This device is marketed under the brand name Hot Axios Stent and Electrocautery-Enhanced Delivery System. The license holder is Boston Scientific India Pvt. Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Stent System

UID: IMP/MD/2018/000129_af47846a1e9142389a4b5a4c07185858_e3097f33b12a47dbd606b7c49ce662d8

Brand Name

Hot Axios Stent and Electrocautery-Enhanced Delivery System

License Holder

Boston Scientific India Pvt. Ltd.,

Device Class

Class C

Approving Authority

CDSCO

Product Information

Indicated for use to facilitate transgastric or transduodenal endoscopic drainage of: •a pancreatic pseudocyst or a walled-off necrosis with ≥ 70% fluid content •gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery •the bile duct after failed ERCP in patients with biliary obstruction due to a malignant stricture

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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