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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 NumberS003
Date Received08/28/2008
Decision Date06/05/2009
Withdrawal Date12/03/2010
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES BASED ON THE ADDITIONAL CLINICAL 12 MONTH SAFETY AND EFFICACY DATA SUBMITTED TO EXTEND THE INITIAL 6 MONTH SAFETY AND EFFICACY DATA.
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