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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 Injectable Gel Implants
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP050047
Supplement NumberS066
Date Received12/17/2018
Decision Date03/13/2019
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the addition of a 0.55 mL-fill volume configuration in the same 1.0 mL COC syringe for Juvéderm Ultra, Juvéderm Ultra XC, and Juvéderm Ultra Plus XC.
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