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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 NameEVOLENCE COLLAGEN FILLER
Classification Nameimplant, dermal, for aesthetic use
ApplicantCOLBAR LIFESCIENCE LTD.
PMA NumberP070013
Date Received04/30/2007
Decision Date06/27/2008
Withdrawal Date 12/03/2010
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 08M-0402
Notice Date 07/16/2008
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the evolence collagen filler, which is indicated for the correction of moderate to deep facial wrinkles and folds such as nasolabial folds.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S005 
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