BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P120006 · Supplement: S015 · Decision Feb 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION IX ILIAC STENT GRAFT
    PMA Number
    P120006
    Supplement Number
    S015
    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 2, 2015
    Date Received
    August 7, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL THE TO ADD A LARGER DIAMETER ILIAC LIMB AND ILIAC EXTENSION, A LONGERLENGTH ILIAC LIMB, AND DECREASE THE DELIVERY SYSTEM PROFILE FOR EACH ILIAC LIMB AND ILIAC EXTENSIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OVATION PRIMEABDOMINAL STENT GRAFT SYSTEM WITH THE OVATION IX ILIAC STENT GRAFT AND IS INDICATED FOR THETREATMENT OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS HAVING THE VASCULAR MORPHOLOGY SUITABLEFOR ENDOVASCULAR REPAIR, INCLUDING:1) ADEQUATEILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES (FEMORALCUTDOWN OR PERCUTANEOUS), DEVICES AND/OR ACCESSORIES;2) PROXIMAL AORTIC LANDING ZONE:A) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM AT 13MM BELOW THE INFERIOR RENAL ARTERY, AND B) WITH AN AORTIC ANGLE OF < 60 DEGREES IF PROXIMAL NECK IS 10 ¿ MM DEGREES IF PROXIMAL NECK IS < 10 MM; AND 3) DISTAL ILIAC LANDING ZONE:A) WITH A LENGTH OF AT LEAST 10 MM, ANDB) WITH AN INNER WALL DIAMETER OF NO LESS THAN 8 MM AND NO GREATER THAN 25 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