BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Light Source System, Diagnostic Endoscopic

    PMA: P050027 · Supplement: S001 · Decision Aug 10, 2010
    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
    S001
    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
    August 10, 2010
    Date Received
    June 11, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) REPLACEMENT OF THE EXISTING KARL STORZ CAMERA CONTROL UNIT (CCU), TRADE NAME ¿TRICAM SL,¿ WITH A NEW MODEL TO BE MARKETED UNDER THE TRADE NAME ¿TRICAM SL II¿; AND 2) MINOR LABELING CHANGES TO REFLECT THE CHANGE IN THE CCU TRADE NAME.

    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