BEUDAMED
    FDA Registration Active 🇺🇸 United States

    XEN Glaucoma Treatment System

    Reg #: 2011068 · FEI: 2011068 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ALLERGAN SALES, LLC
    Registration Number
    2011068
    FEI Number
    2011068
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2525 DUPONT DR
    City
    IRVINE
    State
    CA
    ZIP
    92612
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161457

    Owner / Operator

    Firm Name
    AbbVie, Inc.
    Operator Number
    2011068
    Address
    2525 DUPONT DRIVE, --
    City
    Irvine
    State
    CA
    Postal Code
    92612
    Country
    US
    Correspondent
    James P Wabby

    Products

    Device Name Product Code
    Implant, Eye Valve KYF

    Proprietary Names

    XEN Glaucoma Treatment System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility