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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
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
Supplement NumberS004
Date Received05/27/2009
Decision Date08/28/2009
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR THE ADDITION OF A NEW BOVINE PERICARDIUM SUPPLIER USED IN THE MANUFACTURE OF THE DEVICE.
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