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

    Telescope, Implantable, Miniature

    PMA: P050034 · Supplement: S012 · Decision Jan 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Telescope, Implantable, Miniature
    Trade Name
    IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X
    PMA Number
    P050034
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    NCJ
    Generic Name
    Telescope, implantable, miniature
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 15, 2014
    Date Received
    December 12, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    POSSIBILITY OF REWORK AND RETESTING ACTIVITIES.

    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