BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P990037 · Supplement: S010 · Decision Apr 30, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    VASCULAR SOLUTIONS DUETT SEALING DEVICE
    PMA Number
    P990037
    Supplement Number
    S010
    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 30, 2002
    Date Received
    February 27, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGING THE SUPPLIER FROM COOK PHARMACEUTICALS TO CHESAPEAKE BIOLOGICAL LABORATORIES. THIS CHANGE WILL ALSO AFFECT THE APPROVED DILUENT. SPECIFICALLY, THE CURRENT APPROVED BUFFERING AGENT COMPONENT, 0.1% TROLAMINE NF (TEA) WILL BE CHANGED TO 0.1% TROMETHAMINE USP (TRIS).

    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