BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P160042 · Decision Aug 4, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    REVANESSE ULTRA
    PMA Number
    P160042
    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
    August 4, 2017
    Date Received
    September 22, 2016
    Expedited Review
    N
    Docket Number
    17M-4711

    Advisory Committee Statement

    Approval for the Revanesse Ultra. The device is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults 22 years of age or more.

    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