BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Pressure Lowering Implant

    PMA: P170034 · Supplement: S011 · Decision Aug 28, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Intraocular Pressure Lowering Implant
    Trade Name
    Hydrus® Microstent
    PMA Number
    P170034
    Supplement Number
    S011
    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
    August 28, 2024
    Date Received
    August 30, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a manufacturing site located at Alcon Research, LLC, 714 Columbia Avenue, Sinking Spring, PA 19608, for incoming acceptance activities, component cleaning, assembly, in-process acceptance activities, label printing, packaging, final acceptance activities, bioburden and bacterial endotoxin (BET) testing and a manufacturing site located at Steris AST, 23 Elizabeth Drive, Chester, NY 10918, for gamma irradiation sterilization of the Hydrus Microstent

    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