BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Intraocular Pressure Lowering Implant

    PMA: P080030 · Supplement: S009 · Decision Jun 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Intraocular Pressure Lowering Implant
    Trade Name
    GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
    PMA Number
    P080030
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    OGO
    Generic Name
    Intraocular pressure lowering implant
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 20, 2013
    Date Received
    May 23, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER OF STEARALKONIUM HEPARIN.

    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