- Device
- WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System and WATCHMAN FLX Pro Left Atrial Appendage
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S068
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2024-04-24
- Decision code
- OK30
- Date received
- 2024-03-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of updates to the laser cut toolpath files which control the final shape of the laser cut frame of the WATCHMAN FLX and WATCHMAN FLX Pro implants