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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 VOLUMA XC
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP110033
Supplement NumberS021
Date Received03/21/2016
Decision Date09/12/2016
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT01197495
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the labeling for Juvederm Voluma XC has been revised as follows: 1) to include the results of the completed post-approval study; 2) to include revisions to the postmarket surveillance summary; and 3) to include minor revisions intended to harmonize the directions with those of other Juvederm products.
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