BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P110033 · Supplement: S099 · Decision Jun 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    SKINVIVE by JUVEDERM®
    PMA Number
    P110033
    Supplement Number
    S099
    Device Class
    FDA Class 3
    Product Code
    LMH
    Generic Name
    Implant, dermal, for aesthetic use
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 11, 2026
    Date Received
    May 13, 2025
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee 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

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LMH Implant, Dermal, For Aesthetic Use