BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transvenous Temporary Phrenic Nerve Stimulator

    PMA: P240012 · Decision Dec 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Transvenous Temporary Phrenic Nerve Stimulator
    Trade Name
    AeroPace® System
    PMA Number
    P240012
    Device Class
    FDA Class 3
    Product Code
    SDL
    Generic Name
    Transvenous temporary phrenic nerve stimulator
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 4, 2024
    Date Received
    April 8, 2024
    Expedited Review
    N

    Advisory Committee Statement

    Approval for AeroPace® System. The AeroPace System is indicated to improve weaning success – increase weaning, reduce ventilator days, and reduce reintubation - in patients ages 18 years or older on mechanical ventilation >= 96 hours and who have not weaned.

    Classifications

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

    Product Code Device Name
    SDL Transvenous Temporary Phrenic Nerve Stimulator