BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P050052 · Supplement: S019 · Decision Jul 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    RADIESSE INJECTABLE IMPLANT
    PMA Number
    P050052
    Supplement Number
    S019
    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 13, 2009
    Date Received
    January 14, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE TO PROVIDE DETAILED INSTRUCTIONS FOR MIXING RADIESSE WITH 2% LIDOCAINE HCL (RESULTING IN A FINAL CONCENTRATION OF 0.3% LIDOCAINE) PRIOR TO INJECTION FOR THE INDICATED USE OF SUBDERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS. THE MIXING OF RADIESSE AND LIDOCAINE IS TO BE ACCOMPLISHED USING A MIXING KIT THAT WILL BE MADE AVAILABLE SEPARATE FROM THE RADIESSE DEVICE.

    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