BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030006 · Supplement: S005 · Decision Jun 30, 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
    PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER
    PMA Number
    P030006
    Supplement Number
    S005
    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 30, 2005
    Date Received
    March 23, 2005
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ACCELLENT JUAREZ (MANUFACTURING SITE) LOCATED IN, CHIHUAHUA, MEXICO; ACCELLENT EL PASO (WAREHOUSE) LOCATED IN EL PASO, TEXAS; AND STERIGENICS INTERNATIONAL, INC. (STERILIZER) LOCATED IN SANTA TERESA, NEW MEXICO.

    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