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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMITROFLOW AORTIC PERICARDIAL HEART VALVE
Generic Nameheart-valve, non-allograft tissue
ApplicantCORCYM Canada Corp.
5005 North Fraser Way
Burnaby V5J 5
PMA NumberP060038
Date Received12/18/2006
Decision Date10/23/2007
Withdrawal Date 10/17/2022
Product Code LWR 
Docket Number 07M-0410
Notice Date 11/09/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MITROFLOW AORTIC PERICARDIAL HEART VALVE, SIZES 19, 21, 23, 25, AND 27 MM. THE DEVICE IS INTENDED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S014 S015 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 
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