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

    Stent, Central Venous

    PMA: P980033 · Supplement: S012 · Decision Jan 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stent, Central Venous
    Trade Name
    WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
    PMA Number
    P980033
    Supplement Number
    S012
    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
    January 14, 2005
    Date Received
    December 20, 2004
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES IN THE MANUFACTURING PROCESS: 1) INTRODUCTION OF A TIP TUG TEST ON-LINE AT THE FINAL INSPECTION STEP, 2) INTRODUCTION OF AN AUTOMATED AUTO-FEED SYSTEM TO THE EXISTING SWAGER UNIT, AND 3) INTRODUCTION OF SEMI-AUTOMATED MANUFACTURING SIDE ARM CONNECTORS AS AN ALTERNATIVE TO THE MANUAL MANUFACTURING PROCESS.

    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