BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

    PMA: P920023 · Supplement: S002 · Decision Sep 27, 1996
    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
    S002
    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
    September 27, 1996
    Date Received
    September 9, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO INCREASE THE NUMBER OF INVESTIGATIONAL SITES FROM 7 TO 8 FOR THE "POST APPROVAL STUDY FOR THE UROLUME ENDOPROSTHESIS FOR TREATING RECURRENT BULBAR URETHRAL STRICTURE DISEASE

    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