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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceMITROFLOW AORTIC PERICARDIAL HEART VALVE
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
Applicant
LivaNova Canada Corp.
5005 north fraser way
burnaby V5J 5
PMA NumberP060038
Date Received12/18/2006
Decision Date10/23/2007
Product Code
LWR[ Registered Establishments with LWR ]
Docket Number 07M-0410
Notice Date 11/09/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
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 
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