BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    PMA: P920023 · Supplement: S015 · Decision Jul 22, 2004
    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 ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY
    PMA Number
    P920023
    Supplement Number
    S015
    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
    Decision Code
    APPR
    Decision Date
    July 22, 2004
    Date Received
    July 1, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO CONCLUDE THE BENIGN PROSTATIC HYPERTROPHY PORTION OF THE UROLUME POST-APPROVAL STUDY AND TO INCLUDE THE PROBABILITY OF EXPLANT DUE TO TISSUE RESPONSE AT 10 YEARS IN THE LABELING.

    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