BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

    PMA: P920023 · Supplement: S006 · Decision Oct 2, 1998
    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 ENDOPROSTHESIS
    PMA Number
    P920023
    Supplement Number
    S006
    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
    October 2, 1998
    Date Received
    September 24, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of a warning to the device labeling to reflect an unexpected adverse event.

    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