BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P040002 · Supplement: S038 · Decision Aug 22, 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 STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM
    PMA Number
    P040002
    Supplement Number
    S038
    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
    August 22, 2012
    Date Received
    July 5, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR STAND-ALONE DELIVERY SYSTEM FOR THE STRAIGHT AND TAPERED LIMB EXTENSION STENT GRAFTS AND FOR THE FLARED LIMB EXTENSIONS GRAFTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM AS AN ACCESSORY TO THE AFX AAA ENDOVASCULAR SYSTEM WHICH IS INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH AAA.

    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