BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S005 · Decision Sep 2, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM
    PMA Number
    P960043
    Supplement Number
    S005
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 2, 1998
    Date Received
    March 9, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a modified Percutaneous Vascular Surgical (PVS) System. The device, as modified, will be marketed under the trade name Prostar(R) XL 10 French Percutaneous Vascular Surgical (PVS) System and is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8.5F to 10F sheaths.