BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

    PMA: P840029 · Supplement: S008 · Decision May 11, 1993
    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
    HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM
    PMA Number
    P840029
    Supplement Number
    S008
    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
    Decision Code
    APPR
    Decision Date
    May 11, 1993
    Date Received
    January 6, 1992
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    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