HSA · registration DE0508058Boston Scientific MANTIS™ Clips
- Registration number
- DE0508058
- Model name
- MANTIS™ Clip; MANTIS™ Clip; MANTIS™ Clip; MANTIS™ Clip
- Model identifier
- M00521420; M00521421; M00521422; M00521423
- Registration date
- May 03, 2023
- Source update date
- July 01, 2024
- Risk class
- Class C
- Product owner
- Boston Scientific Corporation
- Registrant / registration holder
- BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
The MANTIS Clip is intended for clip placement within the gastrointestinal (GI) tract for the purpose of: 1. Endoscopic marking 2. Hemostasis for: Mucosal/sub-mucosal defects < 3 cm, Bleeding ulcers, Arteries < 2 mm, Polyps < 1.5 cm in diameter, Diverticula in the colon; Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; 4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively
- Product owner address
- 300 Boston Scientific Way, Marlborough, MA 01752-1234, UNITED STATES
- Registrant address
- 9 NORTH BUONA VISTA DRIVE, #20-01, THE METROPOLIS, Singapore 138588
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.