BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P020004 · Supplement: S075 · Decision Nov 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    GORE EXCLUDER AAA ENDOPROSTHESIS
    PMA Number
    P020004
    Supplement Number
    S075
    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
    November 20, 2012
    Date Received
    October 4, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODIFICATION OF THE DELIVERY SYSTEM FOR THE FOLLOWING DEVICE COMPONENTS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS ON THE SIM-PULL (ORIGINAL) AND C3 (EMDS) CATHETERS IN ORDER TO LOWER THEIR DELIVERY PROFILES AS OUTLINED BELOW: 1) 16, 18 AND 20 MM CONTRALATERAL LEGS FROM 18 FR TO 12 FR; 2) 23 MM CONTRALATERAL LEG FROM 18 FR TO 14 FR; 3) 27 MM COLATERAL LEG FROM 18 FR TO 15 FR; 4) 23, 26, 28.5 MM AORTIC EXTENDERS FROM 18 FR TO 16 FR; 5) 32 MM AORTIC EXTENDER FROM 20 FR TO 17 FR; 6) 31 MM TRUNK-IPSILATERAL LEG WITH SIM-PULL DELIVERY SYSTEM FROM 20 FR TO 18 FR AND 7) 31 MM TRUNK-IPSILATERAL LEG WITH C3 DELIVERY SYSTEM FROM 20 FR TO 18 FR.

    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