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

    Telescope, Implantable, Miniature

    PMA: P050034 · Supplement: S005 · Decision Mar 31, 2011
    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
    S005
    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
    March 31, 2011
    Date Received
    March 2, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE THE BIOLOGICAL INDICATOR USED IN THE STERILIZATION PROCESS AND TO ADD AN OPTION FOR A SECOND FULL CYCLE STERILIZATION (DOUBLE STERILIZATION) TO THE MANUFACTURING PROCESS IF REQUIRED.

    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