BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P070014 · Decision Feb 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM
    PMA Number
    P070014
    Device Class
    FDA Class 3
    Product Code
    NIP
    Generic Name
    STENT, SUPERFICIAL FEMORAL ARTERY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 13, 2009
    Date Received
    May 25, 2007
    Expedited Review
    N
    Docket Number
    09M-0127

    Advisory Committee Statement

    APPROVAL FOR THE LIFESTENT FLEXSTAR AND FLEXSTAR XL VASCULAR STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVEMENT OF LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS UP TO 160 MM IN LENGTH IN THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.00 - 6.5 MM.

    Classifications

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

    Product Code Device Name
    NIP Stent, Superficial Femoral Artery