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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameJUVEDERM VOLUMA XC
Classification Nameimplant, dermal, for aesthetic use
ApplicantALLERGAN
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 
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