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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 ULTRA XC INJECTABLE GEL
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP050047
Supplement NumberS044
Date Received01/27/2015
Decision Date09/30/2015
Product Code LMH 
Docket Number 15M-3519
Notice Date 10/30/2015
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT01197495
Supplement TypePanel 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 THE JUVÉDERM ULTRA XC. THIS DEVICE IS INDICATED FOR:1) JUVÉDERM ULTRA XC INJECTABLE GEL IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS); AND 2) JUVÉDERM ULTRA XC IS INDICATED FOR INJECTION INTO THE LIPS AND PERIORAL AREA FOR LIP AUGMENTATION IN ADULTS OVER THE AGE OF 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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