- Device
- WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S072
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2024-11-01
- Decision code
- OK30
- Date received
- 2024-10-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change from a manual to an automated inspection process of broken anchors on the WATCHMAN FLX and WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System implant frames