|
Device | WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System |
Generic Name | System, appendage closure, left atrial |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P130013 |
Supplement Number | S059 |
Date Received | 09/20/2023 |
Decision Date | 10/31/2023 |
Product Code |
NGV |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the protocol (amended via email on October 26, 2023) for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P130013/S057. |