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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceREPEL-CV BIORESORBABLE ADHESION BARRIER
Generic NameBarrier, adhesion, cardiovascular
ApplicantPathfinder Cell Therapy, Inc.
12 Bow St.
Cambridge, MA 02138
PMA NumberP070005
Supplement NumberS003
Date Received02/21/2014
Decision Date04/30/2014
Withdrawal Date11/03/2015
Product Code OBD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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