BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Valve, Pulmonary

    PMA: P180002 · Supplement: S027 · Decision May 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Valve, Pulmonary
    Trade Name
    Zephyr Endobronchial Valve System
    PMA Number
    P180002
    Supplement Number
    S027
    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
    May 13, 2024
    Date Received
    February 13, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the change of using a modified funnel component for the Endobronchial Loader System included with the Zephyr 5.5 Endobronchial Valve (EBV)

    Classifications

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

    Product Code Device Name
    NJK Valve, Pulmonary