BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P160042 · Supplement: S020 · Decision Mar 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    Revanesse Versa, Revanesse Versa+ with Lidocaine, Revanesse Versa 1.2 mL, Revanesse Versa+ with Lidocaine 1.2 mL, Revane
    PMA Number
    P160042
    Supplement Number
    S020
    Device Class
    FDA Class 3
    Product Code
    LMH
    Generic Name
    Implant, dermal, for aesthetic use
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 22, 2023
    Date Received
    February 21, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change to the stopper, which is a component of the syringe system of the 1.0 and 1.2mL configurations of Revanesse Versa, Revanesse Versa+ with Lidocaine, and Revanesse Lips+ with Lidocaine.

    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