BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Photodynamic Therapy

    PMA: P990021 · Decision Jun 30, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Laser, Photodynamic Therapy
    Trade Name
    DIOMED 630 PDT LASER
    PMA Number
    P990021
    Device Class
    FDA Class 3
    Product Code
    MVF
    Generic Name
    SYSTEM, LASER, PHOTODYNAMIC THERAPY
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 30, 2000
    Date Received
    May 4, 1999
    Expedited Review
    N
    Docket Number
    00M-1387

    Advisory Committee Statement

    APPROVAL FOR THE DIOMED 630 PDT LASER, MODEL T2USA. THIS DEVICE IS INDICATED FOR USE IN PHOTODYNAMIC THERAPY WITH PHOTOFRIN (PORFIMER SODIUM) AS A SOURCE OF ACTIVATION OF PHOTOFRIN FOR: A) PALLIATION OF PATIENTS WITH COMPLETELY OBSTRUCTING ESOPHAGEAL CANCER, OR OF PATIENTS WITH PARTIALLY OBSTRUCTING ESOPHAGEAL CANCER WHO, IN THE OPINION OF THEIR PHYSICIAN, CANNOT BE SATISFACTORILY TREATED WITH ND:YAG LASER THERAPY. B) REDUCTION OF OBSTRUCTING AND PALLIATION OF SYMPTOMS IN PATIENTS WITH COMPLET

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MVF System, Laser, Photodynamic Therapy