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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 MODEL LX
Generic Nameheart-valve, non-allograft tissue
ApplicantCorcym Canada Corp
5005 N. Fraser Way
Burnaby V5J 5M1
PMA NumberP060038
Supplement NumberS002
Date Received12/29/2008
Decision Date02/27/2009
Withdrawal Date10/17/2022
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MANUFACTURING PROCESS IMPROVEMENTS TO THE AORTIC PERICARDIAL HEART VALVE MODEL 12. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDE THE TRADE NAME MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
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