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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 TRANSCATHETER HEART VALVE AND ACCESSORIES
Generic Nameaortic valve, prosthesis, percutaneously delivered
ApplicantEDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, CA 92614
PMA NumberP100041
Supplement NumberS016
Date Received11/13/2012
Decision Date12/10/2012
Withdrawal Date 03/18/2019
Product Code NPT 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
USE OF A QUALITY MANAGEMENT SYSTEM SOFTWARE.
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