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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 NameJUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS
Classification Nameimplant, dermal, for aesthetic use
Generic Namejuvederm gel implants
ApplicantALLERGAN
PMA NumberP050047
Date Received12/05/2005
Decision Date06/02/2006
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 06M-0235
Notice Date 06/29/2006
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 juvederm 24hv, juvederm 30 and juvederm 30hv gel implants. The 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
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S027 S028 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S039 
S041 S042 
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