- Device
- WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S083
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2026-02-12
- Decision code
- OK30
- Date received
- 2026-02-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of an alternate radiopaque (RO) marker crimper system to be used in addition to the existing crimper system for manufacturing the WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System