BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Pressure Lowering Implant

    PMA: P080030 · Decision Jun 25, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Intraocular Pressure Lowering Implant
    Trade Name
    GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
    PMA Number
    P080030
    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 25, 2012
    Date Received
    December 19, 2008
    Expedited Review
    N
    Docket Number
    12M-0712

    Advisory Committee Statement

    APPROVAL FOR THE GLAUKOS ISTENT® TRABECULAR MICRO-BYPASS STENT (MODELS: GTS-100R, GTS-100L) AND INSERTER (GTS-L00I). THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH CATARACT SURGERY FOR THE REDUCTION OFINTRAOCULAR PRESSURE (IOP) IN ADULT PATIENTS WITH MILD TO MODERATE OPEN-ANGLE GLAUCOMA CURRENTLY TREATED WITH OCULAR HYPOTENSIVE MEDICATION.

    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