BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P040044 · Supplement: S062 · Decision Mar 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE)
    PMA Number
    P040044
    Supplement Number
    S062
    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
    March 3, 2015
    Date Received
    December 19, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR MODIFICATIONS TO THE MYNX ACE DEVICE THAT INVOLVE BUTTON 3, THE PACKAGING TRAY, AND INSTRUCTIONS FOR USE (IFU) ASSOCIATED WITH BUTTON 3.

    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