BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P990037 · Supplement: S028 · Decision Dec 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    DUETT PRO SEALING DEVICE, MODEL 1010
    PMA Number
    P990037
    Supplement Number
    S028
    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
    December 17, 2008
    Date Received
    October 21, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO EXTENT THE SHELF LIFE OF THE SODIUM PHOSPHATE PROCOAGULANT DILUENT, USED ONLY IN THE DUET PRO SEALING DEVICE, MODEL 1010, FROM 2 YEARS TO 5 YEARS.

    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