Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | WATCHMAN FLX Left Atrial Appendage Closure 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 | S047 |
Date Received | 04/07/2022 |
Decision Date | 05/06/2022 |
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 Process devices using the reduced EtO S756 sterilization cycle at the BSC Coventry Rhode Island, BSC Galway Ireland, and Steris Tullamore Ireland facilities. |
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