- Device
- WATCHMAN FLXTM Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLXTM Pro Left Atrial Appendage Closu
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S085
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2026-04-23
- Decision code
- OK30
- Date received
- 2026-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add an alternate broken strut inspection system for the WATCHMAN FLX™ Left Atrial Appendage (LAA) Closure Device with Delivery System and WATCHMAN FLX™ Pro LAA Closure Device with Delivery System