BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Light Source System, Diagnostic Endoscopic

    PMA: P050027 · Supplement: S003 · Decision Aug 27, 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
    S003
    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 27, 2012
    Date Received
    May 29, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATE STERILIZATION METHOD, STERRAD NX, FOR THE FLUID LIGHT CABLE DEVICE COMPONENT WITHIN THE DEVICE.

    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