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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.
 
DeviceEDWARDS SAPIEN XT TRANSCATHETER HEART VAlVE
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP130009
Supplement NumberS066
Date Received11/15/2016
Decision Date05/01/2017
Product Code NPT 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the Edwards Singapore facility for manufacturing components used in Edwards surgical and transcatheter heart valves.
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