BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P990037 · Supplement: S023 · Decision Sep 2, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    DUETT PROSEALING DEVICE (MODEL 1010), DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210), AND D-STAT FLOWABLE HEMOSTAT...
    PMA Number
    P990037
    Supplement Number
    S023
    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
    September 2, 2005
    Date Received
    August 5, 2005
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE PROCEDURE FOR DETERMINING ACCEPTANCE OF THE LIMULUS AMEBOCYTE LEVEL (LAL) TEST RESULTS.

    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