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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.
 
DeviceARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
SUNEVA MEDICAL, INC.
5879 pacific center blvd.
san diego, CA 92121
PMA NumberP020012
Date Received04/01/2002
Decision Date10/27/2006
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 06M-0455
Notice Date 11/08/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the artefill, which is indicated for correction of nasolabial folds.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S003 S006 S007 S008 S009 S011 S012 
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