Stent System
- UID
- IMP/MD/2018/000129_af47846a1e9142389a4b5a4c07185858_e3097f33b12a47dbd606b7c49ce662d8
- Device class
- Class C
- Brand name
- Hot Axios Stent and Electrocautery-Enhanced Delivery System
- License holder
- Boston Scientific India Pvt. Ltd.,
- 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
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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