- Device
- WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX™ Pro Left Atrial Appendage Closure
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S084
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2026-05-18
- Decision code
- APPR
- Date received
- 2026-02-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for introduction of an alternative insourced Core Wire Jacket with minor design changes for the Delivery Systems of the WATCHMAN FLX™ and WATCHMAN FLX™ Pro LAA Closure Devices with Delivery Systems.