BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P970008 · Decision Aug 22, 1997
    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
    TARGIS (T3) SYSTEM
    PMA Number
    P970008
    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
    August 22, 1997
    Date Received
    February 24, 1997
    Expedited Review
    N
    Docket Number
    97M-0457

    Advisory Committee Statement

    Approval for the T3(R) Targeted Transurethral Thermoablation System: Model 4000. This device is indicated to relieve symptoms associated with benign prostatic hyperplasia (BPH) and is indicated for men with prostatic lengths of 30 to 50 millimeters.

    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