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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.
 
Trade NameMITROFLOW AORTIC PERICARDIAL HEART VALVE
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
ApplicantSORIN GROUP USA INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S014 S015 S017 S018 S019 
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