BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P790002 · Supplement: S019 · Decision Jul 27, 1998
    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
    S019
    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
    July 27, 1998
    Date Received
    June 24, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for revision of the indications and usage section of the labeling for Models 1200, 1020-S, 1026, and 101, to include the definition of nonunion recommended by the Orthopedic and Rehabilitation Devices Panel on April 28, 1998 and required per FDA's letter dated June 3, 1998 (i.e., "nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").

    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