- Device
- WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System WATCHMAN FLX™ Pro Left Atrial Appendage Closure D
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S089
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2026-08-21
- Decision code
- OK30
- Date received
- 2026-07-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of parametric release and an alternate biological indicator at the sterilization sites