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

    Valve, Pulmonary

    PMA: P180007 · Supplement: S015 · Decision May 7, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Valve, Pulmonary
    Trade Name
    Spiration Valve System (SVS)
    PMA Number
    P180007
    Supplement Number
    S015
    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
    May 7, 2026
    Date Received
    April 15, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The firm is submitting this 30-Day Notice of a change in the verification and validation process of the Water Treatment System. The firm is adding endotoxin testing for the water samples and related process modifications to the manufacturing work instruction.

    Classifications

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

    Product Code Device Name
    NJK Valve, Pulmonary