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 | Edwards Commander Delivery System |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P140031 |
Supplement Number | S143 |
Date Received | 08/09/2022 |
Decision Date | 03/09/2023 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the following manufacturing sites to conduct ethylene oxide sterilization of the Commander Delivery System (Models 9600LDS23, 9750CM23, 9600LDS26, and 9750CM26): (1) Sterigenics, Belgium, located at Zoning Industriel de Petit-Rechain Avenue Andre Ernst 21 Verviers Liege, B-4800 BE, and (2) STERIS Tullamore, located at IDA Business and Technology Park, Tullamore Offaly, IE R35 X865 |
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