BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S046 · Decision Nov 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    CLOSER XL SUTURE MEDIATED CLOSURE (SMC) SYSTEM
    PMA Number
    P960043
    Supplement Number
    S046
    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
    November 25, 2003
    Date Received
    June 17, 2003
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR VARIOUS DIMENSIONAL CHANGES WHICH RESULT IN A LARGER VERSION OF THE ORIGINAL DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLOSER XL SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURES FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITES OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING 8 FR SHEATHS.

    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