HSA · registration DE0509269Boston Scientific Agile™ Esophageal Fully Covered RMV OTW Stent System
SingaporeGastroenterology & UrologyClass CBoston Scientific Corporation
Official record identity
- Registration number
- DE0509269
- Model name
- Agile™ Esophageal Fully Covered RMV OTW; Agile™ Esophageal Fully Covered RMV OTW; Agile™ Esophageal Fully Covered RMV OTW; Agile™ Esophageal Fully Covered RMV OTW
- Model identifier
- M00517790; M00517800; M00517810; M00517820
- Registration date
- May 08, 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 RMV 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 and treating refractory benign esophageal strictures.
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.