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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 and Sapien 3 Ultra Transcatheter Heart Valves
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP140031
Supplement NumberS107
Date Received01/27/2020
Decision Date07/22/2020
Product Code NPT 
Advisory Committee Cardiovascular
Clinical TrialsNCT02675114
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifying the labeling to remove the precaution regarding patients with a congenital bicuspid aortic valve.
Post-Approval StudyShow Report Schedule and Study Progress
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