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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
Classification Namebarrier, adhesion, cardiovascular
Generic Namebarrier, adhesion, cardiovascular
Applicant
PATHFINDER CELL THERAPY INC.
12 bow street
cambridge, MA 02138
PMA NumberP070005
Date Received01/30/2007
Decision Date03/06/2009
Withdrawal Date 11/03/2015
Product Code
OBD[ Registered Establishments with OBD ]
Docket Number 09M-0135
Notice Date 03/11/2009
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 
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