BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S083 · Decision Jan 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    PERCLOSE PROGLIDE/PERCLOSE AT SUTURE MEDIATED CLOSURE SYSTEMS AND SNARED KNOT PUSHER
    PMA Number
    P960043
    Supplement Number
    S083
    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
    January 16, 2014
    Date Received
    July 18, 2013
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF AN INTERNAL FACILITY AS AN ADDITIONAL SUPPLIER OF THREE EXTRUDED COMPONENTS.

    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