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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 supplement. The device description may have changed. Be sure to look at the original PMA 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
Supplement NumberS003
Date Received08/28/2008
Decision Date06/05/2009
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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