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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.
 
DeviceNOVAFLEX DELIVERY SYSTEM
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP130009
Supplement NumberS016
Date Received11/13/2014
Decision Date07/21/2015
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 IMPLEMENTATION OF THE USE OF A MODIFIED HYPOTUBEDURING THE SLOTTED SHAFT TO BALLOON CATHETER BONDING PROCESS FOR THE NOVAFLEX+ DELIVERY SYSTEM.
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