BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Iliac Covered Stent, Arterial

    PMA: P160024 · Supplement: S012 · Decision Aug 23, 2022
    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
    S012
    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
    August 23, 2022
    Date Received
    February 24, 2022
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Angiomed GmbH & Co. Medizintechnik KG, Wachhausstrasse 6, Karlsruhe Baden-Wurttemberg 76227, Germany for supplying the bare metal stent component.

    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