BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    PMA: P920023 · Decision May 6, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent
    Trade Name
    UROLUME ENDOPROSTHESIS
    PMA Number
    P920023
    Device Class
    FDA Class 3
    Product Code
    MES
    Generic Name
    STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    May 6, 1996
    Date Received
    May 12, 1992
    Expedited Review
    N
    Docket Number
    96M-0356

    Advisory Committee Statement

    APPROVAL FOR THE UROLUME ENDORETHRAL PROSTHESIS FOR URETHRAL STRICTURES (REFERRED TO AS UROLUME HEREINAFTER)

    Classifications

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

    Product Code Device Name
    MES Stent, Urethral, Bulbous, Permanent Or Semi-Permanent