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 | 9600CR Crimper |
Generic Name | Pulmonary valve prosthesis percutaneously delivered |
Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
PMA Number | P200015 |
Supplement Number | S016 |
Date Received | 11/03/2021 |
Decision Date | 01/04/2022 |
Product Code |
NPV |
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 the Edwards Añasco Puerto Rico manufacturing site to manufacture the Crimper 9600CR, located at State Road 402, KM 1.4, Industrial Park, Añasco, PR 00610. |
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