BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P110023 · Supplement: S034 · Decision Jun 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
    PMA Number
    P110023
    Supplement Number
    S034
    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
    June 7, 2022
    Date Received
    May 9, 2022
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the IFU to include a troubleshooting technique during partial deployment events

    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