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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
ApplicantSORIN GROUP USA INC.
PMA NumberP060038
Supplement NumberS012
Date Received04/12/2012
Decision Date10/09/2012
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the device.
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