BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Diaphragmatic/Phrenic Nerve Stimulator

    PMA: P860026 · Decision Jan 5, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Implanted Diaphragmatic/Phrenic Nerve Stimulator
    Trade Name
    DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
    PMA Number
    P860026
    Device Class
    FDA Class 3
    Product Code
    GZE
    Generic Name
    implanted diaphragmatic/phrenic nerve Stimulator
    Regulation Number
    882.5830
    Medical Specialty
    Neurology
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 5, 1987
    Date Received
    July 3, 1986
    Expedited Review
    N
    Docket Number
    87M-0022

    Classifications

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

    Product Code Device Name
    GZE Implanted Diaphragmatic/Phrenic Nerve Stimulator