BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P850007 · Supplement: S020 · Decision Mar 9, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    PHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS
    PMA Number
    P850007
    Supplement Number
    S020
    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
    March 9, 2000
    Date Received
    August 25, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to modify the device labeling to include Patient Registry data in addition to the original data contained in the PMA

    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