BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P040044 · Supplement: S008 · Decision Jul 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    MYNX VASCULAR CLOSURE DEVICE
    PMA Number
    P040044
    Supplement Number
    S008
    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
    July 22, 2008
    Date Received
    June 3, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGING THE METHOD OF ATTACHMENT OF THE TENSION PLUNGER TO THE COREWIRE OF THE MYNX VASCULAR CLOSURE DEVICE TO OVERMOLD THE TENSION PLUNGER DIRECTLY ONTO THE COREWIRE.

    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