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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 Heart Valve
Generic Nameheart-valve, non-allograft tissue
ApplicantCorcym Canada Corp
5005 N. Fraser Way
Burnaby V5J 5M1
PMA NumberP130011
Supplement NumberS011
Date Received06/29/2022
Decision Date07/28/2022
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Decrease in the number of samples used in the Limulus Amoebocyte Lysate testing performed per sterilization batch.
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