BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P080007 · Supplement: S007 · Decision Nov 16, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    LIFESTAR VASCULAR STENT SYSTEMS
    PMA Number
    P080007
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    NIO
    Generic Name
    STENT, ILIAC
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 16, 2011
    Date Received
    September 26, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REMOVAL OF THE PCRFORMAXX GRIP ON THE DELIVERY SYSTEM, THE ADDITION OF A SMALLER PACKAGING CONFIGURATION, AND MINOR LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFESTAR VASCULAR STENT SYSTEM AND IS INDICATED FOR THE TREATMENT OF ILIAC OCCLUSIVE DISEASE IN PATIENTS WITH SYMPTOMATIC VASCULAR DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 126 MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NIO Stent, Iliac