BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P040044 · Supplement: S056 · Decision Jul 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    MYNXGRIP VASCULAR CLOSURE DEVICE
    PMA Number
    P040044
    Supplement Number
    S056
    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 30, 2014
    Date Received
    May 2, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO EXPAND THE INDICATIONS FOR USE TO INCLUDE CLOSURE OF VENOUS ACCESS SITES IN ADDITION TO THE CURRENTLY APPROVED USE FOR CLOSURE OF ARTERIAL ACCESS SITES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNXGRIP VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL AND FEMORAL VENOUS ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 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