BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    PMA: P820088 · Supplement: S017 · Decision Jan 20, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Rf/Microwave Hyperthermia, Cancer Treatment
    Trade Name
    BSD-500 HYPERTHERMIA SYSTEM
    PMA Number
    P820088
    Supplement Number
    S017
    Device Class
    FDA Class 3
    Product Code
    LOC
    Generic Name
    System, rf/microwave hyperthermia, cancer treatment
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 20, 2004
    Date Received
    September 26, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO REPLACE THE GENERATOR APPROVED IN PMA P820088/S005. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, BSD-500 HYPERTHERMIA SYSTEM AND IS INDICATED FOR TREATMENT OF SOLID MALIGNANT TUMORS BY LOCALIZED HEAT DELIVERY.

    Classifications

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

    Product Code Device Name
    LOC System, Rf/Microwave Hyperthermia, Cancer Treatment