BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    PMA: P920023 · Supplement: S023 · Decision Nov 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent
    Trade Name
    AMS UROLUME ENDOPROSTHESIS
    PMA Number
    P920023
    Supplement Number
    S023
    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
    November 23, 2011
    Date Received
    March 26, 2008
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION OF THE DEVICE LABELING TO INCLUDE THE RESULTS OF POST APPROVAL STUDIES.

    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