BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Central Venous

    PMA: P980033 · Supplement: S064 · Decision Feb 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stent, Central Venous
    Trade Name
    Wallstent™ Venous Endoprosthesis with Unistep Plus™ Delivery System
    PMA Number
    P980033
    Supplement Number
    S064
    Device Class
    FDA Class 3
    Product Code
    QKJ
    Generic Name
    Stent, central venous
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 20, 2024
    Date Received
    September 6, 2023
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    an alternate supplier of an ingredient used to make the resin for the tapered tips and luer connector of all Wallstent delivery systems

    Classifications

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

    Product Code Device Name
    QKJ Stent, Central Venous