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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.
Classification Nameimplant, dermal, for aesthetic use
PMA NumberP050033
Date Received09/02/2005
Decision Date12/20/2006
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 06M-0531
Notice Date 12/26/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the cosmetic tissue augmentation product. This device is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S012 S013 S014 S015 S016 S017 S018 S019