BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P040044 · Supplement: S040 · Decision Jan 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    MYNXGRIP VASCULAR CLOSURE DEVICE (6F/7F)
    PMA Number
    P040044
    Supplement Number
    S040
    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 13, 2012
    Date Received
    November 14, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR INTEGRATING THE CATHETER DELIVERY SYSTEM OF THE MYNXCADENCE DEVICE WITH THE HYDROGEL SEALANT OF THE MYNX WITH GRIP TECHNOLOGY DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNXGRIP VASCULAR CLOSURE DEVICE AND ISINDICATED FOR USE TO SEAL FEMORAL ARTERIAL ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 6F OR 7F PROCEDURAL SHEATH.

    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