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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 TRANSCATHETER HEART VALVE
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP140031
Supplement NumberS003
Date Received10/07/2015
Decision Date01/26/2016
Product Code NPT 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR VARIOUS DESIGN AND MANUFACTURING CHANGES TO THE EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, MODEL 9600TFX, INCLUDING CHANGE IN MATERIAL SPECIFICATION FOR THE POLYETHYLENE TEREPHTHALATE (PET) RIBBON, CHANGE IN SUTURE MATERIAL, AND REDUCTION IN THE NUMBER OF PERMANENT STITCHES.
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