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

    Pulmonary Stent

    PMA: P220004 · Supplement: S002 · Decision Sep 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Pulmonary Stent
    Trade Name
    PALMAZ MULLINS XD Pulmonary Stent
    PMA Number
    P220004
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    QWC
    Generic Name
    Pulmonary stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 5, 2024
    Date Received
    August 6, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    an updated packaging configuration without physical Instructions for Use

    Classifications

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

    Product Code Device Name
    QWC Pulmonary Stent