BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Light Source System, Diagnostic Endoscopic

    PMA: P050027 · Supplement: S013 · Decision Oct 23, 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
    S013
    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
    October 23, 2018
    Date Received
    July 20, 2018
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following alternate sterilization methods for the PDD Camera Heads: STERRAD NX Standard Cycle, STERRAD 100 NX Standard and Duo Cycles, V-Pro 60 Non-Lumen and Lumen Cycles.

    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