BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P910066 · Supplement: S024 · Decision Dec 10, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE
    PMA Number
    P910066
    Supplement Number
    S024
    Device Class
    FDA Class 3
    Product Code
    LOF
    Generic Name
    Stimulator, bone growth, non-invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 10, 2007
    Date Received
    October 12, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODIFICATION OF THE EXISTING COIL GEOMETRY, THE ADDITION OF A WIRED CONTROL BOX, THE RECONFIGURATION OF THE PATIENT PADDING SYSTEM, AND THE REMOVAL OF THE INFRARED PATIENT COMPLIANCE COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE AND IS INDICATED FOR THE NON-INVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES.

    Classifications

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

    Product Code Device Name
    LOF Stimulator, Bone Growth, Non-Invasive