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 | SAPIEN 3 Ultra Transcatheter Heart Valve System |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P140031 |
Supplement Number | S099 |
Date Received | 10/21/2019 |
Decision Date | 01/27/2021 |
Product Code |
NPT |
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 Costa Rica manufacturing site to manufacture the SAPIEN 3 Ultra transcatheter heart valve (Model 9750TFX, sizes 20mm, 23mm, and 26mm), located at:Zona Franca La Lima, De la entrada de Pequeno Mundo 100 mts oeste y 200 mts surFinca 31 y 32Guadalupe, CartagoCosta Rica 30106 |
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