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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
Classification Nameimplant, dermal, for aesthetic use
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[ Registered Establishments with 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: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S033 S034 S035 S036 S037 S038 
S039 S041 S043 S044 S045 S046 
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