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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEVOLENCE COLLAGEN FILLER
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
COLBAR LIFESCIENCE LTD.
9 hamenofim st.
herzliya 46733
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S005 
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