BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P100021 · Supplement: S091 · Decision May 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf
    PMA Number
    P100021
    Supplement Number
    S091
    Device Class
    FDA Class 3
    Product Code
    MIH
    Generic Name
    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 21, 2021
    Date Received
    April 23, 2021
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities.

    Classifications

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

    Product Code Device Name
    MIH System, Endovascular Graft, Aortic Aneurysm Treatment