BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Pressure Lowering Implant

    PMA: P080030 · Supplement: S013 · Decision Aug 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Intraocular Pressure Lowering Implant
    Trade Name
    ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
    PMA Number
    P080030
    Supplement Number
    S013
    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 7, 2015
    Date Received
    February 9, 2015
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO UPDATE YOUR LABELING TO INCLUDE THE RESULTS OF YOUR POST-APPROVAL STUDY (PAS) FOR THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM, EXTENDED FOLLOW-UP OF THE INVESTIGATIONAL DEVICE EXEMPTION (IDE) COHORT STUDY.

    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