BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S044 · Decision Apr 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM
    PMA Number
    P960043
    Supplement Number
    S044
    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
    April 4, 2003
    Date Received
    March 3, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO: REPLACE THE BRAINED SUTURE WITH A MONOFILAMENT POLYPROPYLENE SUTURE; COMBINE THE INSTRUCTIONS FOR USE OF THE PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND THE CHITO-SEAL DEVICE INTO A SINGLE PAMPHLET. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PERCLOSE A-T MONOFILAMENT 6 FR. 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 8 FR. SHEATHS. THE PERCLOSE A-T MONOFILAMENT 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