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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceSAPIEN 3 Ultra Transcatheter Heart Valve System
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP140031
Supplement NumberS099
Date Received10/21/2019
Decision Date01/27/2021
Product Code NPT 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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