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

    Implant, Dermal, For Aesthetic Use

    PMA: P050052 · Supplement: S037 · Decision Oct 17, 2012
    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- 1.5CC, 8071M0, RADIESSE INJECTABLE IMPLANT-0.8CC, 8069M0, RADIESSE INJECTABLE IMPLANT-0.3CC
    PMA Number
    P050052
    Supplement Number
    S037
    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
    October 17, 2012
    Date Received
    September 20, 2012
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF DEFECT CATEGORIES TO THE INCOMING INSPECTION PROCEDURES BASED ON RISK AND COMMENSURATE WITH SEVERITY.

    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