BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S038 · Decision Apr 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    THE CLOSURE 6 FR., S 6 FR. AND II 6 FR. SUTURE MEDIATED CLOSURE SYSTEMS
    PMA Number
    P960043
    Supplement Number
    S038
    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 29, 2002
    Date Received
    March 26, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DESIGN CHANGE TO THE SUTURE TRIMMER, AN ACCESSORY DEVICE TO THE CLOSER SYSTEMS PREVIOUSLY APPROVED UNDER PMAS P960043/S027 AND S032. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUTURE TRIMMER AND IS INDICATED, AS AN ACCESSORY DEVICE, 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 TIME 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