BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Invasive Bone Growth

    PMA: P790005 · Supplement: S047 · Decision May 6, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stimulator, Invasive Bone Growth
    Trade Name
    ORTHOGEN/OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR
    PMA Number
    P790005
    Supplement Number
    S047
    Device Class
    FDA Class 3
    Product Code
    LOE
    Generic Name
    Stimulator, invasive bone growth
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 6, 2011
    Date Received
    April 8, 2011
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MANUFACTURING CHANGES INVOLVING THE VERIFICATION OF ALCOHOL STERILITY AND THE MAGNET OVERRIDING TEST FIXTURE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOE Stimulator, Invasive Bone Growth