BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Telescope, Implantable, Miniature

    PMA: P050034 · Supplement: S016 · Decision Dec 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Telescope, Implantable, Miniature
    Trade Name
    IMPLANTABLE MINIATURE TELESCOPE (IMT)
    PMA Number
    P050034
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    NCJ
    Generic Name
    Telescope, implantable, miniature
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 20, 2016
    Date Received
    September 23, 2016
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a design change to reposition the eyelet on each haptic (loop) of the carrier of the IMT to the distal end of the haptic.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NCJ Telescope, Implantable, Miniature