BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P020035 · Supplement: S001 · Decision Dec 18, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    X-PRESS TRIMMER - ACCESSORY TO THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM
    PMA Number
    P020035
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 18, 2003
    Date Received
    November 4, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW ACCESSORY THAT INCORPORATES THE KNOT PUSHER AND SUTURE CUTTER ACCESSORIES INTO A SINGLE DEVICE. THIS NEWLY CREATED ACCESSORY WILL BE MARKETED UNDER THE TRADE NAME X-PRESS TRIMMER, WHICH ALLOWS THE OPERATOR TO PUSH THE CLINCH KNOT AND CUT THE SUTURE BELOW THE SKIN LINE FOLLOWING THE USE OF THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM.

    Classifications

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

    Product Code Device Name
    MGB Device, Hemostasis, Vascular