BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Pressure Lowering Implant

    PMA: P170043 · Decision Jun 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Intraocular Pressure Lowering Implant
    Trade Name
    iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
    PMA Number
    P170043
    Device Class
    FDA Class 3
    Product Code
    OGO
    Generic Name
    Intraocular pressure lowering implant
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 21, 2018
    Date Received
    December 21, 2017
    Expedited Review
    N
    Docket Number
    18M-2460

    Advisory Committee Statement

    Approval for the iStent inject® Trabecular Micro-Bypass System (Model G2-M-IS). This device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OGO Intraocular Pressure Lowering Implant