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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 NumberS053
Date Received03/30/2020
Decision Date05/28/2021
Product Code LMH 
Docket Number 21M-0527
Notice Date 06/03/2021
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT03418545
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for JUVEDERM VOLBELLA XC for expanding the indications to include the improvement of infraorbital hollowing in adults over the age of 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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