BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    PMA: P920023 · Supplement: S016 · Decision Aug 8, 2003
    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
    Supplement Number
    S016
    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
    August 8, 2003
    Date Received
    July 11, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITIONAL DETAILED INSTRUCTIONS FOR PROSTHESIS REMOVAL AFTER UROTHELIAL COVERAGE.

    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