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

    Valve, Pulmonary

    PMA: P180002 · Supplement: S030 · Decision Mar 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Valve, Pulmonary
    Trade Name
    Zephyr Endobronchial Valve (EBV) System
    PMA Number
    P180002
    Supplement Number
    S030
    Device Class
    FDA Class 3
    Product Code
    NJK
    Generic Name
    Valve, pulmonary
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 17, 2026
    Date Received
    February 26, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Removal of the ambient aeration step of the ethylene oxide (EO) sterilization process.

    Classifications

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

    Product Code Device Name
    NJK Valve, Pulmonary