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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 TRANSFEMORAL ACCESSORIES
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP100041
Supplement NumberS036
Date Received07/10/2013
Decision Date08/09/2013
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  
CHANGE TO THE QUALITY INSPECTION SAMPLING PLAN FOR THE RETROFLEX BALLOON CATHETER GUIDEWIRE SHAFT.
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