BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

    PMA: P000043 · Supplement: S010 · Decision Feb 8, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
    Trade Name
    TMX-3000 THERMATRX OFFICE THERMOTHERAPY SYSTEM
    PMA Number
    P000043
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    MEQ
    Generic Name
    System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 8, 2007
    Date Received
    January 17, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN UPGRADE OF THE DEVICE INCLUDING A MODIFICATION OF THE MAIN CONSOLE, COMPUTER AND SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TMX-3000 THERMATRX OFFICE THERMOTHERAPY SYSTEM AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WHO HAVE A MINIMUM PROSTATIC URETHRA LENGTH F 25 MM AND A TOTAL PROSTATE VOLUME BETWEEN 30 AND 100 CC.

    Classifications

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

    Product Code Device Name
    MEQ System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy