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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.
 
DeviceARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER
Generic Nameimplant, dermal, for aesthetic use
ApplicantSUNEVA MEDICAL, INC.
5879 pacific center blvd.
san diego, CA 92121
PMA NumberP020012
Date Received04/01/2002
Decision Date10/27/2006
Product Code LMH 
Docket Number 06M-0455
Notice Date 11/08/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ARTEFILL, WHICH IS INDICATED FOR CORRECTION OF NASOLABIAL FOLDS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S003 S006 S007 S008 S009 S011 S012 S013 S014 S015 S017 
S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 
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