- Device
- WATCHMAN FLX™ Left Atrial Appendage (LAA) Closure Device with Delivery System; WATCHMAN FLX™ Pro Left Atrial Appendage (
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S080
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2025-12-12
- Decision code
- OK30
- Date received
- 2025-10-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add a Gantry-assisted Wetline process as alternative to the current electropolishing processes for WATCHMAN FLX™ and WATCHMAN FLX™ Pro Left Atrial Appendage (LAA) Closure Devices with Delivery Systems