BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

    PMA: P200018 · Decision Mar 31, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
    Trade Name
    NeuRX Diaphragm Pacing System (DPS)
    PMA Number
    P200018
    Device Class
    FDA Class 3
    Product Code
    OIR
    Generic Name
    diaphragmatic/phrenic nerve laparoscopically-implanted stimulator
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 31, 2023
    Date Received
    March 12, 2020
    Expedited Review
    N
    Docket Number
    23M-1306

    Advisory Committee Statement

    Approval for the NeuRx DPS® is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.

    Classifications

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

    Product Code Device Name
    OIR Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator