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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.
 
DeviceJUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP050047
Date Received12/05/2005
Decision Date06/02/2006
Product Code LMH 
Docket Number 06M-0235
Notice Date 06/29/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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 S040 S041 S042 S043 S044 S045 S046 S047 S048 S050 S051 
S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 
S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 
S076 S077 S078 S079 S080 S081 S082 S083 S085 S086 S087 S088 
S089 S090 S091 S092 S093 S094 S095 S096 
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