HSA · registration DE0510218Boston Scientific Watchman FLX™ Pro Left Atrial Appendage Closure Device with Delivery System
- Registration number
- DE0510218
- Model name
- Watchman FLX™ Pro; Watchman FLX™ Pro; Watchman FLX™ Pro; Watchman FLX™ Pro; Watchman FLX™ Pro; Watchman FLX™ Pro
- Model identifier
- M635WU60200; M635WU60240; M635WU60270; M635WU60310; M635WU60350; M635WU60400
- Registration date
- January 08, 2025
- Risk class
- Class D
- Product owner
- Boston Scientific Coporation
- Registrant / registration holder
- BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
WATCHMAN FLX Pro is intended for percutaneous, transcatheter closure of the left atrial appendage. The WATCHMAN FLX Pro Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: • Are at increased risk for stroke and systemic embolism based on CHA2DS2-VASc1 scores and are recommended for anticoagulation therapy; • Are deemed by their physicians to be suitable for anticoagulation therapy; and • Have an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.
- Product owner address
- 300 Boston Scientific Way, Marlborough, MA01752-1234, 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.