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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
ApplicantTiger Aesthetics Medical, LLC
555 E. N. Ln. Suite 5000, Bldg. D
Conshohocken, PA 19428
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
Predetermined Change Control Plan AuthorizedNo
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:  S009 S006 S007 S008 S003 S013 S014 S011 S012 S028 S017 
S015 S030 S041 S040 S039 S047 S019 S020 S021 S022 S023 S026 
S024 S025 S018 S027 S034 S035 S031 S032 S033 S029 S036 S037 
S045 S038 S044 S046 S048 S049 S051 S052 
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