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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.
 
DeviceSJM BIOCOR VALVE / SJM BIOCOR SUPRA 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 NumberP040021
Date Received04/19/2004
Decision Date08/05/2005
Product Code
LWR[ Registered Establishments with LWR ]
Docket Number 05M-0321
Notice Date 08/24/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the sjm biocor valve and the sjm biocor supra valve.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 S028 S029 
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