HSA · registration DE0507749Boston Scientific Agile™ Esophageal Partially Covered Stent System
SingaporeGastroenterology & UrologyClass CBoston Scientific Corporation
Official record identity
- Registration number
- DE0507749
- Model name
- Agile™ Esophageal Partially Covered; Agile™ Esophageal Partially Covered; Agile™ Esophageal Partially Covered; Agile™ Esophageal Partially Covered; Agile™ Esophageal Partially Covered; Agile™ Esophageal Partially Covered; Agile™ Esophageal Partially Covered; Agile™ Esophageal Partially Covered
- Model identifier
- M00517200; M00517210; M00517220; M00517230; M00517240; M00517250; M00517260; M00517270
- Registration date
- February 06, 2023
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 stent is intended to be used in patients with malignant (cancerous) esophageal strictures (narrowing of the food pipe) and is not intended to be removed. The stent is designed as a device to improve dysphagia (difficulty swallowing) and maintain esophageal patency (opening of the esophagus) to allow for passage of food and liquids.
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.