BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P050047 · Supplement: S044 · Decision Sep 30, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    JUVEDERM ULTRA XC INJECTABLE GEL
    PMA Number
    P050047
    Supplement Number
    S044
    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
    September 30, 2015
    Date Received
    January 27, 2015
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    15M-3519

    Advisory Committee Statement

    APPROVAL FOR THE JUVÉDERM ULTRA XC. THIS DEVICE IS INDICATED FOR:1) JUVÉDERM ULTRA XC INJECTABLE GEL IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS); AND 2) JUVÉDERM ULTRA XC IS INDICATED FOR INJECTION INTO THE LIPS AND PERIORAL AREA FOR LIP AUGMENTATION 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