BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P970008 · Supplement: S029 · Decision Mar 23, 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
    UROLOGIX TARGIS SYSTEM
    PMA Number
    P970008
    Supplement Number
    S029
    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
    March 23, 2006
    Date Received
    May 10, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A RADIO FREQUENCY IDENTIFICATION (RFID) SYSTEM TO PREVENT REUSE OF THE DISPOSABLE DEVICE COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM AND IS INDICATED FOR THE DELIVERY OF MICROWAVE ENERGY TO THE PROSTATE FOR THE TREATMENT OF BPH IN A SINGLE SESSION. IT IS INDICATED FOR PATIENTS WITH PROSTATIC LENGTHS OF 30 TO 50 MM.

    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