BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P040044 · Supplement: S048 · Decision May 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    MYNXCADENCE AND MYNXGRIP VASCULAR DEVICES
    PMA Number
    P040044
    Supplement Number
    S048
    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
    May 17, 2013
    Date Received
    February 22, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CLARIFICATION AND SIMPLIFICATION OF THE LANGUAGE USED INTHE INSTRUCTION FOR USE AND REMOVAL OF THE STERILIZATION INDICATOR LABEL FROM THE DEVICE POUCH FOR THE MYNX CADENCE VASCULAR CLOSURE DEVICE, 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE, AND 5F MYNXGRIP VASCULAR CLOSURE DEVICE.

    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