BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Iliac Covered Stent, Arterial

    PMA: P160024 · Supplement: S007 · Decision Sep 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Iliac Covered Stent, Arterial
    Trade Name
    LifeStream Balloon Expandable Vascular Covered Stent
    PMA Number
    P160024
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    PRL
    Generic Name
    Iliac covered stent, arterial
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 9, 2019
    Date Received
    June 27, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the LifeStream Balloon Expandable Vascular Covered Stent labeling to incorporate the 3-year results of the BOLSTER Clinical Study.

    Classifications

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

    Product Code Device Name
    PRL Iliac Covered Stent, Arterial