BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P990037 · Supplement: S014 · Decision Mar 14, 2003
    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
    S014
    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
    March 14, 2003
    Date Received
    February 24, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITIONAL INCOMING INSPECTION REQUIREMENT TO MEASURE THE OUTER DIAMETER (OD) OF THE DISTAL END OF THE STOPCOCK AND TO TIGHTEN THE TOLERANCE AROUND THE ORIGINALLY APPROVED OD ON THE STOPCOCK DISTAL END.

    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