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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 TRANSCATHETER HEART VALVE (THV)
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP110021
Supplement NumberS045
Date Received09/22/2014
Decision Date10/20/2014
Withdrawal Date03/18/2019
Product Code NPT 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
IMPLEMENTATION OF AN ADDITIONAL OD INSPECTION TO THE SAPIEN® AND SAPIEN XT TRANSCATHETER HEART VALVES, MODELS 9000TFX AND 9300TFX.
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