BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P070027 · Supplement: S011 · Decision Feb 4, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    TALENT ABDOMINAL STENT GRAFT SYSTEM
    PMA Number
    P070027
    Supplement Number
    S011
    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
    February 4, 2010
    Date Received
    August 10, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING THE TALENT CONVERTER STENT GRAFT AND TALENT OCCLUDER ASLINE EXTENSIONS TO THE ALREADY EXISTING TALENT ABDOMINAL PRODUCT FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TALENT CONVERTER STENT GRAFT SYSTEM WITHXCELERANT HYDRO DELIVERY SYSTEM & TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM. THE TALENT CONVERTER IS INDICATED FOR SECONDARY ENDOVASCULAR INTERVENTION IN PATIENTS HAVING RECEIVED PRIOR ENDOVASCULAR REPAIR OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS USING THE TALENTOR ANEURX BIFURCATED STENT GRAFTS IN WHICH THERE IS INADEQUATE PROXIMAL FIXATION, SEAL, OVERLAPPING OF MODULAR COMPONENTS OR UNATTAINABLE CONTRALATERAL LIMB CANNULATION. THE TALENT OCCLUDER IS INDICATED FOR ENDOLUMINAL OCCLUSION OF THE COMMON ILIAC ARTERY IN ORDER TO PREVENTRETROGRADE BLOOD INTO THE ANEURYSM SAC WHEN USED IN CONJUNCTION TO A FEM-FEM BYPASS.

    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