BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P990037 · Supplement: S021 · Decision Jul 14, 2004
    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 DIAGNOSTIC DUETT PRO SEALING DEVICE
    PMA Number
    P990037
    Supplement Number
    S021
    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
    July 14, 2004
    Date Received
    June 15, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFYING THE PRESSURE RELIEF VALVE COMPONENT ON THE CATHETER AND REPLACING THE MIXING 20 GAUGE NEEDLE SYRINGE WITH A NEEDLELESS NON-CORING VIAL ACCESS DEVICE.

    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