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Device | WATCHMAN FLX 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 | S058 |
Date Received | 03/07/2023 |
Decision Date | 03/29/2023 |
Product Code |
NGV |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implement upgraded Implant Loading Stations used to attach the WATCHMAN FLX Implant to the Delivery Sheath. |