BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Light Source System, Diagnostic Endoscopic

    PMA: P050027 · Decision May 28, 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 DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
    PMA Number
    P050027
    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
    May 28, 2010
    Date Received
    July 31, 2005
    Expedited Review
    N
    Docket Number
    10M-0294

    Advisory Committee Statement

    APPROVAL FOR THE KARL STORZPHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM. THE KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHTC (PDD) SYSTEM IN COMBINATION WITH THE OPTICAL IMAGING DRUG CYSVIEW(HEXAMINOLEVULINATE HYDROCHLORIDE) FOR INTRAVESICAL SOLUTION IS INDICATED FOR PHOTODYNAMIC BLUELIGHT CYSTOSCOPY, AS AN ADJUNCT TO WHITE LIGHT CYSTOSCOPY FOR THE DETECTION OF NON-MUSCLE INVASIVEPAPILLARY CANCER OF THE BLADDER IN PATIENTS SUSPECTED OR KNOWN TO HAVE THE LESION ON THE BASIS OF A PRIOR CYSTOSCOPY.

    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