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Device | WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE |
Generic Name | System, appendage closure, left atrial |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P130013 |
Supplement Number | S009 |
Date Received | 05/19/2016 |
Decision Date | 08/04/2016 |
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 a manufacturing site located at Boston Scientific Corporation, Maple Grove Facility located at One Scimed Place, Maple Grove, Minnesota, 55311 as an additional manufacturing site for the Watchman Closure Device with Delivery System. |