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Device | WATCHMAN™ and WATCHMAN FLX™ Left Atrial Appendage Closure Devices with Delivery Systems |
Generic Name | System, appendage closure, left atrial |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P130013 |
Supplement Number | S043 |
Date Received | 03/31/2021 |
Decision Date | 09/02/2022 |
Product Code |
NGV |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of dual antiplatelet therapy (DAPT) as an alterative post-implant antithrombotic medication regimen. |
Post-Approval Study | Show Report Schedule and Study Progress |