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 | Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprostheses |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P860057 |
Supplement Number | S202 |
Date Received | 07/20/2021 |
Decision Date | 12/13/2021 |
Product Code |
DYE |
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 | Yes |
Approval Order Statement Approval for the manufacturing of the Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis (MAGNA Model 3300TFX) at the Edwards Cartago, Costa Rica Facility, limited to cleaning and sterilization of components, bioburden reduction, final assembly, terminal liquid sterilization, and packaging and labeling prior to commercial release. |
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