BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P990037 · Supplement: S012 · Decision Jan 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE SEALING DEVICE
    PMA Number
    P990037
    Supplement Number
    S012
    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
    January 30, 2003
    Date Received
    January 17, 2003
    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 DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE. SPECIFICALLY, 1) REMOVAL OF THE SILICONE GASKET FROM THE PRESSURE RELIEF VALVE DESIGN; 2) REMOVAL OF A LUER LOCK THREAD/ATTACHMENT WHICH WAS USED TO CONNECT THE CATHETER TO THE PRESSURE RELIEF VALVE AND REPLACE WITH AN ADHESIVE BOND; 3) REMOVAL OF THE CAP COVER AND THREADS FROM THE RELIEF VALVE, AND 4) SHORTENING OF THE LENGTH AND HEIGHT OF THE RELIEF VALVE.

    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