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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.
 
DeviceREPEL-CV BIORESORBABLE ADHESION BARRIER
Generic NameBarrier, adhesion, cardiovascular
ApplicantPathfinder Cell Therapy, Inc.
12 Bow St.
Cambridge, MA 02138
PMA NumberP070005
Date Received01/30/2007
Decision Date03/06/2009
Withdrawal Date11/03/2015
Product Code OBD 
Docket Number 09M-0135
Notice Date 03/11/2009
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE REPEL-CV BIORESORBABLE ADHESION BARRIER. THE DEVICE IS INDICATED FOR REDUCING THE SEVERITY OF POST-OPERATIVE CARDIAC ADHESIONS IN PEDIATRIC PATIENTS WHO ARE LIKELY TO REQUIRE REOPERATION VIA STERNOTOMY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S002 S003 
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