BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

    PMA: P840029 · Decision Apr 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
    Trade Name
    MICROVEL(R) WITH HEMASHIELD
    PMA Number
    P840029
    Device Class
    FDA Class 2
    Product Code
    DSY
    Generic Name
    PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    April 26, 1989
    Date Received
    June 28, 1984
    Expedited Review
    N
    Docket Number
    89M-0170

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter