BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Diaphragmatic/Phrenic Nerve Stimulator

    PMA: P860026 · Supplement: S006 · Decision Jul 7, 2000
    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
    PMA Number
    P860026
    Supplement Number
    S006
    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
    July 7, 2000
    Date Received
    April 27, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR PROCESS VALIDATION OF THE PROPOSED DEVICE STERILIZATION PROCEDURE, PROPOSED LABELING FOR THE DEVICE PACKAGING, AND THE PROPOSED CHANGES TO THE INSTRUCTION MANUAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MARK IV AND IS INDICATED FOR PERSONS WHO REQUIRE CHRONIC VENTILATORY SUPPORT BECAUSE OOF UPPER MOTOR NEURON RESPIRATORY MUSCLE PARALYSIS (RMP) OR BECAUSE OF CENTRAL ALVEOLAR HYPOVENTILATION (CAH) AND WHOSE REMAINING PHRENIC NERVE, LUNG, AND DIAPHRAGM FUNCTION

    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