BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Pressure Lowering Implant

    PMA: P150037 · Supplement: S014 · Decision Apr 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Intraocular Pressure Lowering Implant
    Trade Name
    CyPass Micro-Stent
    PMA Number
    P150037
    Supplement Number
    S014
    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
    April 9, 2020
    Date Received
    December 20, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the letter dated October 10, 2019 requesting that you continue the assessment of subjects implanted with the device for a minimum of 10 years to assess the long-term safety profile of the CyPass® System.

    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