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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.
 
DeviceSJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
Generic Nameheart-valve, non-allograft tissue
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP040021
Date Received04/19/2004
Decision Date08/05/2005
Product Code LWR 
Docket Number 05M-0321
Notice Date 08/24/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE SJM BIOCOR VALVE AND THE SJM BIOCOR SUPRA VALVE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S055 S056 
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