BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Diaphragmatic/Phrenic Nerve Stimulator

    PMA: P860026 · Supplement: S009 · Decision Nov 4, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Implanted Diaphragmatic/Phrenic Nerve Stimulator
    Trade Name
    Avery Diaphragm Pacing System (alson known as Breathing Pacemaker System)
    PMA Number
    P860026
    Supplement Number
    S009
    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
    November 4, 2019
    Date Received
    September 27, 2017
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to replace the Mark IV transmitter with the digital Spirit 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