- Device
- WATCHMAN™ and WATCHMAN FLX™ Left Atrial Appendage Closure Devices with Delivery Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S043
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2022-09-02
- Decision code
- APPR
- Date received
- 2021-03-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of dual antiplatelet therapy (DAPT) as an alterative post-implant antithrombotic medication regimen.