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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.
 
DeviceSkinvive by Juvéderm
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP110033
Supplement NumberS059
Date Received02/24/2021
Decision Date05/11/2023
Product Code LMH 
Docket Number 23M-2033
Notice Date 06/08/2023
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT03728309
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 SKINVIVE™ by JUVÉDERM® injectable gel, indicated for intradermal injection to improve facial skin smoothness of the cheeks in adults over the age of 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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