BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Valve, Pulmonary

    PMA: P180002 · Supplement: S024 · Decision Sep 5, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Valve, Pulmonary
    Trade Name
    modified 4.0-LP funnel component
    PMA Number
    P180002
    Supplement Number
    S024
    Device Class
    FDA Class 3
    Product Code
    NJK
    Generic Name
    Valve, pulmonary
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 5, 2023
    Date Received
    June 7, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the proposed design changes to the funnel of the Endobronchial Loader System that is included with the Zephyr 4.0-LP Endobronchial valve model.

    Classifications

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

    Product Code Device Name
    NJK Valve, Pulmonary