BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Diaphragmatic/Phrenic Nerve Stimulator

    PMA: P860026 · Supplement: S008 · Decision Mar 3, 2003
    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
    Supplement Number
    S008
    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
    March 3, 2003
    Date Received
    September 11, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SELECTING A FINAL VALUE OF C22 AND C50 CAPACITORS DURING PRODUCTION TESTING BASED ON PARAMETERS MEASURED WITH CALIBRATED TEST EQUIPMENT TO RESULT IN PEAK OPERATING PERFORMANCE OF THE TRANSMITTER.

    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