BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P020035 · Supplement: S002 · Decision Mar 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    X-SITE SUTURE-MEDIATED CLOSURE DEVICE
    PMA Number
    P020035
    Supplement Number
    S002
    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
    March 3, 2006
    Date Received
    November 30, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR VARIOUS LABELING CHANGES AND ERGONOMIC CHANGES TO THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME X-SITE SUTURE-MEDIATED CLOSURE DEVICE AND IS INDICATED FOR ??THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURES USING SHEATHS LESS THAN OR EQUAL TO 6 FR. THE X-SITE SUTURE-MEDIATED CLOSURE DEVICE IS INTENDED TO REDUCE THE TIME TO H0MOSTASIS, TIME TO AMBULATION (100 FEET), AND TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS, INCLUDING THOSE 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