BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P140002 · Supplement: S031 · Decision Dec 12, 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
    MISAGO® RX Self-expanding Peripheral Stent
    PMA Number
    P140002
    Supplement Number
    S031
    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
    December 12, 2025
    Date Received
    September 15, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    packaging material, performance testing, and label placement changes

    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