BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Central Venous

    PMA: P980033 · Supplement: S006 · Decision Apr 1, 2003
    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
    S006
    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
    April 1, 2003
    Date Received
    March 12, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) MANUAL, NAMELY A MODIFICATION TO THE SIZING REQUIREMENTS OF THE INTRODUCER SHEATHS AND A MODIFICATION TO THE DESCRIPTION OF THE RECOMMENDED GUIDE WIRE TO BE USED WITH THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM.

    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