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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.
 
DeviceEVOLENCE COLLAGEN FILLER
Generic NameImplant, dermal, for aesthetic use
ApplicantColbar Lifescience , Ltd.
9 Hamenofim St.
Herzliya 46733
PMA NumberP070013
Supplement NumberS002
Date Received07/09/2008
Decision Date09/15/2008
Withdrawal Date12/03/2010
Product Code LMH 
Advisory Committee General & Plastic Surgery
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
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY.
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