BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S048 · Decision Feb 11, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE SYSTEM
    PMA Number
    P960043
    Supplement Number
    S048
    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
    February 11, 2004
    Date Received
    September 8, 2003
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NAME CHANGE, FROM PERCLOSE AT MONO-GLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM TO PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PERCLOSE PROGLIDE SUTURE MEDIATED CLOSER (SMC) SYSTEMS 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 CATHETERIZATION PROCEDURES USING 5 TO 8 FR. SHEATHS. THE PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEMS REDUCE THE TIMES TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR 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