- Device
- WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (FLX)
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S045
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2021-08-25
- Decision code
- OK30
- Date received
- 2021-07-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate sterilization site with additional PCDs to sterilize the WATCHMAN FLX LAAC device.