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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 JUVEDERM®
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP110033
Supplement NumberS099
Date Received05/13/2025
Decision Date06/11/2026
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT05316233
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  
SKINVIVE by JUVÉDERM® is indicated for intradermal injection to improve skin smoothness of the cheeks and intradermal and/or subdermal injection to reduce neck lines for improvement of neck appearance in adults over the age of 21
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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