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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.
 
Trade NameREPEL-CV BIORESORBABLE ADHESION BARRIER
Classification Namebarrier, adhesion, cardiovascular
ApplicantPATHFINDER CELL THERAPY INC.
PMA NumberP070005
Date Received01/30/2007
Decision Date03/06/2009
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 
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