BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P020035 · Decision Sep 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM
    PMA Number
    P020035
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 30, 2003
    Date Received
    September 3, 2002
    Expedited Review
    N
    Docket Number
    09M-0406

    Advisory Committee Statement

    APPROVAL FOR THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM. THE DEVICE IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING SHEATHS LESS THAN OR EQUAL TO 6 FRENCH IN SIZE. THE DEVICE IS INTENDED TO REDUCE THE TIME TO HEMOSTASIS, TIME TO AMBULATION (100 FEET), AND TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CARDIAC CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS, INCLUDING THOSE PATIENTS RECEIVING GLYCOPROTEIN IIB/IIIA INHIBITORS.

    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