BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S019 · Decision Nov 22, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CLOSER PERCUTANEOUS VASCULAR SURGERY DEVICE
    PMA Number
    P960043
    Supplement Number
    S019
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 22, 1999
    Date Received
    May 3, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Closer(TM) PVS Device and the following accessories: the Perclose Mini Knot Pusher, Perclose Snared Knot Pusher and the Clincher(TM) Knot Tying Device. The device is indicated for the percutaneous delivery of suture for closing hte common femoral artery access sie of patients who have undergone diagnostic catheterization procedures using 5 to 6 Fr. sheaths. The Closer(TM) 6 Fr. PVS System reduces the times to hemostasis, ambulation (5 meters or 16 feet) and discharge in patients who have undergone diagnostic catherization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations in the device labeling).