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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
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: S003  S014 S015 S016 S004 S052 S059 S065 S067 S061 S062 
S063 S069 S070 S071 S058 S077 S078 S020 S001 S002 S011 S007 
S008 S009 S025 S028 S013 S010 S012 S018 S019 S005 S006 S021 
S022 S023 S026 S027 S024 S029 S030 S036 S033 S046 S047 S044 
S045 S050 S042 S043 S055 S060 S066 S068 S080 S072 S073 S074 
S076 S037 S038 S039 S035 S031 S040 S034 S051 S041 S053 S054 
S056 S057 S048 S081 
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