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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 VOLUMA XC
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP110033
Date Received08/29/2011
Decision Date10/22/2013
Product Code LMH 
Docket Number 13M-1364
Notice Date 11/20/2013
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00978042
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE JUVEDERM VOLUMA TM XC. THIS DEVICE IS INDICATED FOR DEEP (SUBCUTANEOUS AND/OR SUPRAPERIOSTEAL) INJECTION FOR CHEEK AUGMENTATION TO CORRECT AGE-RELATED VOLUME DEFICIT IN THE MIDFACE IN ADULTS OVER THE AGE OF 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S018 S019 S022 S023 S024 S050 S027 S028 S021 S029 S030 
S025 S026 S035 S040 S037 S031 S033 S042 S043 S046 S047 S053 
S054 S067 S063 S065 S062 S074 S076 S079 S084 S085 S086 S095 
S096 S100 S101 S087 S081 S034 S036 S038 S039 S044 S045 S048 
S082 S083 S077 S078 S099 S092 S093 S094 S013 S009 S010 S012 
S001 S002 S011 S003 S004 S020 S014 S015 S016 S055 S007 S008 
S056 S057 S051 S052 S041 S060 S061 S058 S059 S005 S006 S066 
S068 S072 S073 S069 S070 S071 S097 S098 S080 S088 S089 S090 
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