BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S026 · Decision Sep 29, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CLOSER S(TM) 6FR. SMC DEVICE
    PMA Number
    P960043
    Supplement Number
    S026
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 29, 2000
    Date Received
    August 31, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CLOSER S(TM) 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM. THE DEVICE, AS MODIFIED, IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS. THE CLOSER S(TM) 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM REDUCES THE TIMES TO HEMOSTASIS, AMBULATION (5 METERS OR 16 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS (REFER TO PRECAUTIONS, SPECIAL PATIENT POPULATIONS IN THE DEVICE LABELING).