BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P050017 · Supplement: S024 · Decision Jul 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    Zilver Flex(R) 35 Vascular Stent
    PMA Number
    P050017
    Supplement Number
    S024
    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
    July 1, 2025
    Date Received
    September 27, 2024
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    25M-2101

    Advisory Committee Statement

    The Zilver Flex® 35 Vascular Stent is intended to improve the luminal diameter in the treatment of de novo or restenotic symptomatic lesions in the native above-the-knee femoropopliteal arteries with reference vessel diameters from 4 to 7 mm and lesion lengths up to 190 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