BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P110033 · Supplement: S065 · Decision Jul 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    Juvéderm Volux XC
    PMA Number
    P110033
    Supplement Number
    S065
    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
    July 29, 2022
    Date Received
    August 30, 2021
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    22M-1793

    Advisory Committee Statement

    Approved for the indication of subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition

    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