BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Light Source System, Diagnostic Endoscopic

    PMA: P050027 · Supplement: S012 · Decision May 22, 2018
    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
    S012
    Device Class
    FDA Class 3
    Product Code
    OAY
    Generic Name
    Light source system, diagnostic endoscopic
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 22, 2018
    Date Received
    April 23, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Relocation of manufacturing of flexible cystoscope subassemblies.

    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