BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, External Sphincter, Permanent

    PMA: P920023 · Supplement: S007 · Decision Mar 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stent, Urethral, External Sphincter, Permanent
    Trade Name
    UROLUME ENDOPROSTHESIS
    PMA Number
    P920023
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    MXQ
    Generic Name
    Stent, urethral, external sphincter, permanent
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 29, 1999
    Date Received
    October 1, 1998
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    99M-0870

    Classifications

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

    Product Code Device Name
    MXQ Stent, Urethral, External Sphincter, Permanent