BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

    PMA: P920023 · Supplement: S001 · Decision Apr 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stent, Urethral, Prostatic, Permanent Or Semi-Permanent
    Trade Name
    UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
    PMA Number
    P920023
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    MER
    Generic Name
    STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 11, 1997
    Date Received
    May 6, 1996
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    98M-0050

    Advisory Committee Statement

    APPROVAL FOR THE UROLUME(TM) ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY(BPH). THIS DEVICE IS INTENDED TO RELIEVE PROSTATIC OBSTRUCTION SECONDARY TO BPH IN MEN AT LEAST 60 YRS OF AGE, OR MEN UNDER 60 YEARS OF AGE WHO ARE POOR SURGICAL CANDIDATES, AND WHOSE PROSTATES ARE AT LEAST 2.5CM IN LENGTH.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MER Stent, Urethral, Prostatic, Permanent Or Semi-Permanent