BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Light Source System, Diagnostic Endoscopic

    PMA: P050027 · Supplement: S004 · Decision Sep 10, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Light Source System, Diagnostic Endoscopic
    Trade Name
    KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
    PMA Number
    P050027
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    OAY
    Generic Name
    Light source system, diagnostic endoscopic
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 10, 2012
    Date Received
    August 21, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF CORRECTIONS TO THE ETHYLENE OXIDE (ETO) STERILIZATION INSTRUCTIONS CONTAINED IN THE PDD CAMERA HEADS INSTRUCTION CARD, HOPKINS II PDD TELESCOPES INSTRUCTION MANUAL AND TRICAM SL II CAMERA CONTROL UNIT INSTRUCTION MANUAL.

    Classifications

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

    Product Code Device Name
    OAY Light Source System, Diagnostic Endoscopic