- 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
- S067
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2024-04-18
- Decision code
- OK30
- Date received
- 2024-03-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to two specifications associated with the weld size and location as well as the allowable energy used in the Threaded Insert Weld process for the WATCHMAN FLX and WATCHMAN FLX Pro implants