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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceJUVEDERM VOLBELLA XC
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP110033
Supplement NumberS018
Date Received08/03/2015
Decision Date05/31/2016
Product Code LMH 
Docket Number 16M-1401
Notice Date 06/02/2016
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT01998581
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for JUVÉDERM VOLBELLA® XC injectable gel. The device is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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