BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P050037 · Decision Dec 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    RADIESSE 1.3CC AND 0.3CC
    PMA Number
    P050037
    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
    December 22, 2006
    Date Received
    September 29, 2005
    Expedited Review
    N
    Docket Number
    07M-0006

    Advisory Committee Statement

    APPROVAL FOR RADIESSE. THIS DEVICE IS INDICATED FOR SUBDERMAL IMPLANTATION FOR RESTORATION AND/OR CORRECTION OF THE SIGNS OF FACIAL FAT LOSS (LIPOATROPHY) IN PEOPLE WITH HUMAN IMMUNODEFICIENCY VIRUS.

    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