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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
Applicant
Allergan
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 Trials NCT00978042
Expedited Review Granted? No
Combination Product Yes
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S029 S030 S025 S024 S027 S006 S005 S001 
S010 S013 S009 S004 S008 S003 S016 S014 S023 
S022 S026 S028 S021 S011 S019 S002 S018 S012 
S007 S020 S015 S050 S041 S051 S045 S054 S056 
S048 S036 S034 S035 S039 S037 S038 S057 S044 
S043 S046 S052 S055 S040 S042 S047 S031 S033 
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