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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.
 
Trade NameARTEFILL
Classification Nameimplant, dermal, for aesthetic use
Generic Namedermal implant
ApplicantSUNEVA MEDICAL, INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the artefill, which is indicated for correction of nasolabial folds.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S003 S006 S007 
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