BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030006 · Supplement: S026 · Decision Oct 24, 2014
    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
    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
    October 24, 2014
    Date Received
    May 21, 2014
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REPLACING THE CURRENT SUPPLIER FOR MANIFOLD TUBING, AND TO REPLACE MEDICAL DEVICE ADHESIVE CURRENTLY USED IN MANUFACTURING.

    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