BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S035 · Decision Dec 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM
    PMA Number
    P960043
    Supplement Number
    S035
    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 28, 2001
    Date Received
    November 19, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION OF THE CLOSER S SUTURE-MEDIATED CLOSURE (SMC) DEVICE TO ALLOW FOR A PRE-TIED KNOT UPON DEVICE USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM AND IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS. THE CLOSER II 6 FR. SMC SYSTEM REDUCES THE TIMES TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS.

    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