BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ovation iX Iliac Stent Graft

    Reg #: 3008011247 · FEI: 3008011247 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Endologix LLC
    Registration Number
    3008011247
    FEI Number
    3008011247
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3910 Brickway Blvd
    City
    Santa Rosa
    State
    CA
    ZIP
    95403
    Country
    US

    Regulatory Submissions

    PMA Number
    P120006

    Owner / Operator

    Firm Name
    Endologix LLC
    Operator Number
    9034802
    Address
    2 MUSICK
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Kathryn Simpson

    Products

    Device Name Product Code
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH

    Proprietary Names

    Ovation iX Iliac Stent Graft Ovation Abdominal Stent Graft System Ovation Prime Abdominal Stent Graft System Ovation iX Abdominal Stent Graft System Alto Abdominal Stent Graft System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device