BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P040044 · Supplement: S032 · Decision Jun 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    5F & 6/7F MYNX VASCULAR CLOSURE DEVICE
    PMA Number
    P040044
    Supplement Number
    S032
    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
    June 17, 2010
    Date Received
    May 20, 2010
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO APPLY LIGHT FINGERTIP COMPRESSION PROXIMAL TO THE INSERTION SITE BEFORE DEFLATING AND REMOVING THE BALLOON CATHETER.

    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