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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceST JUDE MEDICAL TRIFECTA VALVE
Generic Nameheart-valve, non-allograft tissue
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP100029
Date Received07/20/2010
Decision Date04/20/2011
Product Code LWR 
Docket Number 11M-0296
Notice Date 05/06/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00475709
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S022 S023 
S024 S025 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S042 S043 S045 S046 S047 S048 S049 
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