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 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 | S025 |
Date Received | 12/07/2018 |
Decision Date | 03/01/2019 |
Product Code |
NGV |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for approval for a manufacturing site, Synergy Health Ireland Ltd., (a STERIS Company), located at IDA Business and Technology Park, Srah, Tullamore, County Offaly, Ireland, as a new ethylene oxide (EO) sterilization site for the WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System. |
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