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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: S022 S023 S024 S050 S027 S028 S008 S009 S010 S013 S021 S029 
S030 S025 S026 S035 S040 S037 S042 S043 S046 S047 S053 S054 
S058 S067 S063 S101 S079 S080 S090 S088 S089 S085 S086 S076 
S034 S036 S038 S039 S044 S045 S048 S052 S056 S051 S041 S055 
S059 S065  S014 S015 S016 S003 S004 S007 S020 S001 S002 
S066 S071 S072 S073 S074 S068 S060 S061 S062 S057 S077 S078 
S087 S091 S092 S093 S094 S099 S100 S012 S018 S019 S011 S005 
S006 S031 S033 S069 S070 S095 S096 S097 S098 S081 S082 S083 
S084 S102 
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