PMA P130013S042
- Device
- WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S042
- Product code
- NGV
- Decision date
- 2021-05-21
- Generic name
- System, appendage closure, left atrial
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S042
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2021-05-21
- Decision code
- APPR
- Date received
- 2021-03-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.