BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Telescope, Implantable, Miniature

    PMA: P050034 · Supplement: S009 · Decision Nov 5, 2013
    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
    S009
    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
    November 5, 2013
    Date Received
    May 15, 2013
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE APPROVED PROFESSIONAL USE INFORMATION AND PATIENT INFORMATION BOOKLET TO ADD INFORMATION OBTAINED FROM POST-APPROVAL STUDY IMT-002-LTME.

    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