PMA P130013S048
- Device
- WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S048
- Product code
- NGV
- Decision date
- 2022-05-19
- Generic name
- System, appendage closure, left atrial
- Approval order statement
- Add an alternate wetline process used the in manufacturing of the WATCHMAN FLX implant.
Current openFDA PMA Record#
- Device
- WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S048
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2022-05-19
- Decision code
- OK30
- Date received
- 2022-04-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate wetline process used the in manufacturing of the WATCHMAN FLX implant.