BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P790002 · Supplement: S016 · Decision Apr 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    EBI BONE HEALING SYSTEM(R)
    PMA Number
    P790002
    Supplement Number
    S016
    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 9, 1996
    Date Received
    June 2, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO LABELING INCLUDING THE ADDITION OF INFORMATION REGARDING "TREATMENT COMPLETION," (AFFECTS PHYSICIAN INSTRUCTION MANUAL), A DESCRIPTION OF THE PMA POPULATION AND ORIGINAL AND FOUR YEAR SUCCESS RATES (AFFECTS PHYSICIAN INSTRUCTION AND PATIENT MANUALS) AND THE ADDITION OF A CONTRAINDICATION FOR PATEINTS WEARING IMPALNTABLE DEFIBRILLATORS (AFFECTS PHYSICIAN INSTRUCTION MANUAL)

    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