BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Telescope, Implantable, Miniature

    PMA: P050034 · Supplement: S014 · Decision Sep 12, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Telescope, Implantable, Miniature
    Trade Name
    IMPLANTABLE MINIATURE TELESCOPE
    PMA Number
    P050034
    Supplement Number
    S014
    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
    September 12, 2014
    Date Received
    June 11, 2014
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS¿ QUAD LUMEN SOFT TIP.

    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