BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P000043 · Supplement: S015 · Decision Dec 15, 2006
    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-2000 THERMATRX OFFICE THERMO THERAPY SYSTEM
    PMA Number
    P000043
    Supplement Number
    S015
    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
    December 15, 2006
    Date Received
    July 19, 2006
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE LABELING TO INCORPORATE THE RESULTS OF THE 5-YEAR POSTAPPROVAL STUDY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TMX-2000 THERMATRX OFFICE THERMO THERAPY SYSTEM AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WHO HAVE A MINIMUM PROSTATIC URETHRA LENGTH OF 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