BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P850007 · Supplement: S018 · Decision Apr 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    PHYSIO-STIM LITE BONE GROWTH STIMULATOR
    PMA Number
    P850007
    Supplement Number
    S018
    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
    April 16, 1997
    Date Received
    May 7, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE DESIGN AND LABELING OF THE PHYSIO-STIM(R) BONE GROWTH STIMULATOR. THE DEVICE, AS MODIFIED, IS TO BE MARKETED UNDER THE TRADE NAME PHYSIO-STIM(R) LITE AND IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING BERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE INJURY AND THE FRACTURE SITE SHOWS NO VISIBLY PROGRESSIVE SIGNS OF HELAING FOR A MINIMUM OF THREE MONTHS (NO CHANGE IN THE FRACTURE CALLUS)

    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