BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

    PMA: P920023 · Supplement: S004 · Decision Jul 15, 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(TM)ENDOPROSTHESIS
    PMA Number
    P920023
    Supplement Number
    S004
    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
    July 15, 1998
    Date Received
    June 22, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval to: 1)increase the number or investigational sites in the post-approval study of new patients (post-approval study#2) under the recurrent bulbar urethral strictures application, and 2) increase the patient enrollment limit to 132 (to include 57 original and 75 new patients) for the post-approval study of the BPH application.

    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