BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P020018 · Supplement: S040 · Decision Apr 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT
    PMA Number
    P020018
    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
    April 4, 2012
    Date Received
    October 7, 2011
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    Y
    Docket Number
    12M-0371

    Advisory Committee Statement

    APPROVAL FOR THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (WITH THE ADJUNCTIVE ZENITH ALIGNMENT STENT). THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OFPATIENTS WITH ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS HAVING MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH REQUIRED INTRODUCTION SYSTEMS;2) NONANEURYSMAL INFRARENAL AORTIC SEGMENT (NECK) PROXIMAL TO THE ANEURYSMS WITH: A) LENGTH >= 4 MM AND UNSUITABLE FOR A NON-FENESTRATED GRAFT. B) DIAMETER <= 31 MM AND >= 19 MM. C) ANGLE < 45 DEGREES RELATIVE TO LONG AXIS OF ANEURYSM. D) ANGLE < 45 DEGREES RELATIVE TO AXIS OF SUPRARENAL AORTA. 3) IPSILATERAL ILIAC ARTERY FIXATION SITE > 30 MM IN LENGTH AND BETWEEN 9 - 21 MM IN DIAMETER; AND CONTRALATERAL ILIAC ARTERY DISTAL FIXATION SITE > 30 MM IN LENGTH AND BETWEEN 7 - 21 MM IN DIAMETER. THE ZENITH ALIGNMENT STENT IS INDICATED FOR USE AS AN ADJUNCT TO THE ZENITH FENESTRATED AAAENDOVASCULAR GRAFT TO SECURE POSITIVE ALIGNMENT OF FENESTRATIONS OR SCALLOPS WITH THE ORIFICE OF AORTIC BRANCH VESSELS HAVING DIAMETERS RANGING FROM 3 TO 8 MM.

    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