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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
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP100041
Supplement NumberS008
Date Received03/08/2012
Decision Date08/20/2012
Withdrawal Date03/18/2019
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 TO ADD THE EDWARDS TRANSCATHETER BALLOON CATHETERS, MODELS 9350BC20 AND 9350BC23 WITH A WORKING BALLOON LENGTH OF 4 CM, AND TO ADD SOME NEW CONTROL ENVIRONMENTS AT THE DRAPER FACILITY IN DRAPER, UTAH TO ACCOMMODATE THE MANUFACTURE OF THESE CATHETERS AT THAT FACILITY.
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