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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.
 
DeviceMITROFLOW AORTIC PERICARDIAL HEART VALVE
Generic Nameheart-valve, non-allograft tissue
ApplicantCorcym Canada Corp
5005 N. Fraser Way
Burnaby V5J 5M1
PMA NumberP060038
Supplement NumberS030
Date Received08/16/2016
Decision Date09/14/2016
Withdrawal Date10/17/2022
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  
Upgrade to the Covered Stent Controlled Environment (CSCE) from a lower ISO cleanroom classification to a higher classification as well as the extension of covered stent manufacturing activities to two additional controlled environments.
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