- Device
- WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Closure D
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S070
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2024-09-23
- Decision code
- APPR
- Date received
- 2024-06-27
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for replacing a manual inspection with an automated inspection method, including modified acceptance criteria, to detect bent struts on the device frame for WATCHMAN FLX™ LAA Closure Device and WATCHMAN FLX™ Pro LAA Closure Device.