BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P040002 · Supplement: S040 · Decision Dec 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    AFX ENDOVASCULAR AAA SYSTEM
    PMA Number
    P040002
    Supplement Number
    S040
    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
    December 28, 2012
    Date Received
    November 8, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF BIFURCATED STENT GRAFT MODELS FOR THE APPROVED AFX ENDOVASCULAR AAA SYSTEM PRODUCT FAMILY. THE NEW MODELS CONTAIN SHORTER AND LONGER BIFURCATED BODIES THAT WILL HAVE THE SAME DIAMETER AS THOSE CURRENTLY APPROVED; AND TO ADD 20MM DIAMETER LIMBS USING THE SAME STENT CAGE.

    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