BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P990037 · Supplement: S025 · Decision Jul 17, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
    PMA Number
    P990037
    Supplement Number
    S025
    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 17, 2007
    Date Received
    June 14, 2007
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE FOLLOWING WARNING TO THE LABELING: ?THE SAFETY AND EFFECTIVENESS OF D-STAT HAS NOT BEEN ESTABLISHED FOR USE TO CONTROL BLEEDING FOLLOWING ORGAN OR TISSUE BIOPSIES. USE OF D-STAT IN THIS SITUATION HAS BEEN REPORTED TO RESULT IN PAIN, SEIZURES, BILE RETENTION, TISSUE NECROSIS, VASCULAR OCCLUSION AND DEATH.?

    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