PMA P130013S044
- Device
- WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S044
- Product code
- NGV
- Decision date
- 2021-05-17
- Generic name
- System, appendage closure, left atrial
- Approval order statement
- Add an additional inspection method for the WATCHMAN FLX weld measurements.
Current openFDA PMA Record#
- Device
- WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S044
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2021-05-17
- Decision code
- OK30
- Date received
- 2021-05-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an additional inspection method for the WATCHMAN FLX weld measurements.