BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P970008 · Supplement: S026 · Decision Jun 16, 2005
    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 FOR THE TREATMENT OF BPH
    PMA Number
    P970008
    Supplement Number
    S026
    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
    June 16, 2005
    Date Received
    February 25, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LONGER VERSION OF THE COOLED THERMOCATH MICROWAVE DELIVERY CATHETER. THE LONGER ANTENNA IS 37 MM COMPARED TO THE 28 MM ANTENNA IN THE CURRENTLY APPROVED COOLED THERMOCATH CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COOLED THERMOCATH 4.5+ AND IS INDICATED FOR MEN WITH PROSTATIC URETHRAL LENGTHS OF 4.5 CM OR GREATER.

    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