HSA · registration DE0509160Boston Scientific Agile™ Esophageal Fully Covered OTW Stent System
SingaporeGastroenterology & UrologyClass CBoston Scientific Corporation
Official record identity
- Registration number
- DE0509160
- Model name
- Agile™ Esophageal Fully Covered OTW; Agile™ Esophageal Fully Covered OTW; Agile™ Esophageal Fully Covered OTW; Agile™ Esophageal Fully Covered OTW
- Model identifier
- M00517750; M00517760; M00517770; M00517780
- Registration date
- April 11, 2024
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Boston Scientific Corporation
- Registrant / registration holder
- BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Official description
The Agile Esophageal Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
Additional source fields
- Product owner address
- 300 Boston Scientific Way, Marlborough, MA 01752, UNITED STATES
- Registrant address
- 9 NORTH BUONA VISTA DRIVE, #20-01, THE METROPOLIS, Singapore 138588
About this record
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.