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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, Juvéderm Ultra XC, Juvéderm Ultra Plus, and Juvéderm Ultra Plus XC
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP050047
Supplement NumberS079
Date Received10/30/2020
Decision Date11/25/2020
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
Approval Order Statement  
Approval for revisions to the patient labeling of Juvéderm® Ultra, Juvéderm® Ultra Plus, Juvéderm® Ultra XC Wrinkles and Folds, Juvéderm® Ultra XC Lips, and Juvéderm® Ultra Plus XC to include updated safety information based on post marketing surveillance data.
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