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

    Stent, Central Venous

    PMA: P980033 · Supplement: S040 · Decision Dec 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stent, Central Venous
    Trade Name
    WALLSTENT SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND UNISTEP PLUS DELIVERY SYSTEM (12 MM VENOUS ENDOPROSTHESIS)
    PMA Number
    P980033
    Supplement Number
    S040
    Device Class
    FDA Class 3
    Product Code
    QKJ
    Generic Name
    Stent, central venous
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 18, 2013
    Date Received
    November 26, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.

    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