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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.
 
DeviceSOLO SMART STENTLESS HEART VALVE
Generic Nameheart-valve, non-allograft tissue
ApplicantCorcym Canada Corp
5005 N. Fraser Way
Burnaby V5J 5M1
PMA NumberP130011
Supplement NumberS001
Date Received06/22/2015
Decision Date07/22/2015
Withdrawal Date08/30/2024
Product Code LWR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFICATION TO THE STERILIZATION PROCESS PARAMETERS, THE INCLUSION OF QUALITY CONTROL TESTS USED ON AN IN-PROCESS DEVICE, AND THE ADDITION OF BATCH TESTING TO THE FINAL STORAGE SOLUTION OF THE SOLO SMART HEART VALVE.
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