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 | Amplatzer Amulet (ACP2) |
Generic Name | System, appendage closure, left atrial |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P200049 |
Supplement Number | S005 |
Date Received | 04/05/2023 |
Decision Date | 05/02/2023 |
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 Addition of two (2) sterilization chambers at the Steris Costa Rica facility to sterilize the subject devices. |
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