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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 AND TRANSAPICAL ACCESSORIES
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEDWARDS LIFESCIENCES LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP110021
Supplement NumberS017
Date Received06/03/2013
Decision Date07/03/2013
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  
THREE NEW FIXTURES USED IN THE MANUFACTURING PROCESS, REMOVAL OF A DEBURR MANDREL TOOL, AND ADDITIONAL INSPECTIONS ASSOCIATED WITH THESE CHANGES.
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