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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.
 
DeviceST JUDE MEDICAL TRIFECTA VALVE
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
Applicant
St. Jude Medical, Inc.
177 e.county rd. b east
st paul, MN 55117
PMA NumberP100029
Date Received07/20/2010
Decision Date04/20/2011
Product Code
LWR[ Registered Establishments with LWR ]
Docket Number 11M-0296
Notice Date 05/06/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00475709
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the st. Jude medical trifecta valve. The trifecta valve is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.
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 S013 S014 S015 S016 S017 S018 
S019 S020 S021 
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