BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P050052 · Supplement: S052 · Decision Jan 30, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    RADIESSE (+) LIDOCAINE DERMAL FILTER
    PMA Number
    P050052
    Supplement Number
    S052
    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
    January 30, 2015
    Date Received
    April 9, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION TO THE FORMULATION, SYRINGE MATERIAL, SPECIFICATIONS, MANUFACTURING PROCESS AND LABELING TO SUPPORT THE ADDITION OF THE LIDOCAINE AND IMPROVE MANUFACTURING EFFICACY. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME,RADIESSE® (+) AND IS INDICATED FOR SUB-DERMAL IMPLANTATION THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, INCLUDING NASOLABIAL FOLDS.

    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