BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Ventilator, High Frequency

    PMA: P850064 · Supplement: S037 · Decision Oct 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Ventilator, High Frequency
    Trade Name
    Model 203 Life Pulse High Frequency Ventilator
    PMA Number
    P850064
    Supplement Number
    S037
    Device Class
    FDA Class 3
    Product Code
    LSZ
    Generic Name
    VENTILATOR, HIGH FREQUENCY
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 19, 2018
    Date Received
    September 20, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The LifePulse High Frequency Ventilator is indicated for use in ventilating critically ill infants with pulmonary interstitial emphysema (PIE). Infants studied ranged in birth weight from 750 to 3,529 grams and in gestational age from 24 to 41 weeks. The LifePulse High Frequency Ventilator is also indicated for use in ventilating critically illinfants with respiratory distress syndrome (RDS) complicated by pulmonary air leaks who are, in the opinion of their physicians, failing on conventional ventilation. The infantsstudied ranged in birth weight from 600 to 3,660 grams and in gestational age from 24 to 38 weeks.

    Classifications

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

    Product Code Device Name
    LSZ Ventilator, High Frequency