BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

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

    PMA: P030006 · Supplement: S015 · Decision Jul 10, 2007
    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
    PMA Number
    P030006
    Supplement Number
    S015
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 10, 2007
    Date Received
    June 14, 2007
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    SIX CHANGES: 1) REVISED WORK IN PROGRESS MANAGEMENT PROCEDURE; 2) A PROCESS DOCUMENT CHANGE; 3) CHANGE IN THE FREQUENCY OF A MAINTENANCE SCHEDULE; 4) CHANGE IN THE IDENTIFICATION OF A PART; 5) CHANGE IN THE TOLERANCE OF A PART; AND 6) CHANGE IN A SUBASSEMBLY TEST.

    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