BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P950014 · Supplement: S026 · Decision Jul 16, 2008
    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 PROSTATRON SYSTEM
    PMA Number
    P950014
    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
    July 16, 2008
    Date Received
    March 14, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN MODIFICATIONS WHICH INCLUDE A NEW CATHETER TIP MATERIAL, RED MARK ADHESIVE, BONDING ADHESIVES, INJECTION MOLD FOR MANUFACTURING THE CATHETER TIP, AND A NEW STERILE BALLOON INFLATION STOPCOCK. THE PRODUCTION OF THE PROSTAPROBE TYPE II, SILICONE, BLUE TREATMENT CATHETER (PART NUMBER 410053-004) WILL BE MANUFACTURED AT MEDTECH COSTA RICA, SA, COSTA RICA, CENTRAL AMERICA.

    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