BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Telescope, Implantable, Miniature

    PMA: P050034 · Supplement: S015 · Decision Jan 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Telescope, Implantable, Miniature
    Trade Name
    VISIONCARE IMPLANTABLE MINIATURE TELESCOPE
    PMA Number
    P050034
    Supplement Number
    S015
    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
    January 27, 2015
    Date Received
    November 28, 2014
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol - OSB
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY PROTOCOL: UPDATED STUDY PROTOCOL WITH THE INCLUSION OF CASE REPORT FORM (CRF) AND STUDY TIMELINE.

    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