- 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
- S086
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2026-07-21
- Decision code
- APPR
- Date received
- 2026-04-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a Delivery Sheath print update to allow for acceptance of a defined number of broken braid wires for the continuous braiding method for WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System and WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System