BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Imaging, Fluorescence

    PMA: P950042 · Supplement: S004 · Decision Sep 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Imaging, Fluorescence
    Trade Name
    PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
    PMA Number
    P950042
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    MRK
    Generic Name
    SYSTEM, IMAGING, FLUORESCENCE
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 5, 2007
    Date Received
    July 18, 2007
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A TRADE NAME CHANGE FROM ONCO-LIFE TO PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MRK System, Imaging, Fluorescence