BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010055 · Decision Dec 23, 2002
    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
    PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH
    PMA Number
    P010055
    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
    December 23, 2002
    Date Received
    September 10, 2001
    Expedited Review
    N
    Docket Number
    03M-0189

    Advisory Committee Statement

    APPROVAL FOR THE PROSTALUND CORETHERM MICROWAVE THERMOTHERAPY SYSTEM. THE PROSTALUND CORETHERM IS A NON-SURGICAL, MINIMALLY INVASIVE DEVICE INTENDED TO RELIEVE SYMPTOMS ASSOCIATED WITH SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) BYE PROSTALUND FEEDBACK TREATMENT (PLFT), AND IS INDICATED FOR MEN WITH PROSTATE SIZE OF 30 TO 100G AND PROSTATIC URETHRA LENGTH >= 35 MM.

    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