BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P120006 · Decision Oct 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    OVATION ABDOMINAL STENT GRAFT SYSTEM
    PMA Number
    P120006
    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
    October 5, 2012
    Date Received
    April 11, 2012
    Expedited Review
    N
    Docket Number
    12M-1110

    Advisory Committee Statement

    APPROVAL FOR THE OVATION ABDOMINAL STENT GRAFT SYSTEM. THIS DEVICE IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINALAORTIC ANEURYSMS HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES; 2) NON-ANEURYSMAL PROXIMAL AORTIC NECK: A) WITH A LENGTH OF AT LEAST 7 MM PROXIMAL TO THE ANEURYSM; B) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM; AND C) WITH AN AORTIC ANGLE OF <= 60 DEGREES IF PROXIMAL NECK IS >= 10 MM AND <=45 DEGREES IF PROXIMAL NECK IS <10 MM. 3) ADEQUATE DISTAL ILIAC LANDING ZONE: A) WITH A LENGTH OF AT LEAST 10 MM; AND WITH AN INNER WALL DIAMETER OF NO LESS THAN 8 MM AND NO GREATER THAN 20 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