BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P110023 · Supplement: S056 · Decision Aug 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
    PMA Number
    P110023
    Supplement Number
    S056
    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
    August 5, 2025
    Date Received
    January 30, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a line extension for the SFA/PPA indication, which includes the addition of a 5.0mm stent diameter and reduction in minimum rated vessel diameter to 4.0 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