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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.
 
DeviceASCENDRA + DELIVERY SYSTEM
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP130009
Supplement NumberS039
Date Received07/24/2015
Decision Date08/07/2015
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  
EXTEND THE APPLICATION AREA OF THE CURRENTLY APPROVED ADHESIVE AT THE Y-CONNECTOR TO GUIDEWIRE SHAFT BOND OF THE ASCENDRA+ DELIVERY SYSTEM AND ADD A QUALITY INSPECTION OF THE ADHESIVE AT BOTH THE Y-CONNECTOR TO GUIDEWIRE SHAFT AND Y-CONNECTOR TO BALLOON SHAFT BOND SITES.
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