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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.
 
DeviceJuvéderm Ultra, Ultra XC, and Ultra Plus XC, Juvéderm Ultra XC
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP050047
Supplement NumberS087
Date Received04/04/2023
Decision Date05/03/2023
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
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 revisions to the clinician labeling and patient labeling of Juvéderm Ultra, Ultra XC, and Ultra Plus XC, Juvéderm Ultra XC, Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, and Juvéderm Volux XC as a result of postmarket surveillance data.
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