BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulmonary Stent

    PMA: P220004 · Decision Jul 21, 2023
    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
    Device Class
    FDA Class 3
    Product Code
    QWC
    Generic Name
    Pulmonary stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 21, 2023
    Date Received
    April 11, 2022
    Expedited Review
    N
    Docket Number
    23M-3903

    Advisory Committee Statement

    Approval of the PALMAZ MULLINS XD Pulmonary Stent. The PALMAZ MULLINS XD Pulmonary Stent is indicated for the non-emergency treatment of pulmonary artery stenosis in pediatric patients who are at least 10kg in weight with two ventricle anatomy.

    Classifications

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

    Product Code Device Name
    QWC Pulmonary Stent