BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P920004 · Supplement: S011 · Decision Oct 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    VASOSEAL (VASCULAR HEMOSTASIS DEVICE)
    PMA Number
    P920004
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 22, 1999
    Date Received
    October 4, 1999
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 30-Day Notice proposed a change in the quality cotnrol tests used to delcare sterility of the VasoSeal(R) Needle Depth Indicator Kit. The change will allow for dosimetric release following gamma radiation sterilization in accordance with ANSI/AAMI/ISO 11137-1995 Requirements for validation and routine control - Radiation sterilization.

    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