BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S049 · Decision Nov 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM
    PMA Number
    P960043
    Supplement Number
    S049
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 25, 2003
    Date Received
    October 27, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE. THESE CHANGES STRENGTHEN THE PROCEDURAL INSTRUCTIONS FOR USING THE DEVICE AND ADD A PRECAUTION TO NOT USE EXCESSIVE FORCE OR TORQUE TO ADVANCE THE DEVICE, STATING THAT SUCH ACTIONS MAY RESULT IN: "IGNIFICANT ARTERIAL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE SURGICAL REMOVAL OF THE DEVICE AND ARTERIAL REPAIR." IN ADDITION TO THESE LABELING CHANGES, YOU HAVE ALSO INDICATED THAT THE PHYSICIAN TRAINING PROTOCOL HAS BEEN REVISED TO FURTHER ADDRESS THIS CONCERN.

    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