BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Prostatic, Semi-Permanent

    PMA: P060010 · Supplement: S008 · Decision Dec 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Stent, Urethral, Prostatic, Semi-Permanent
    Trade Name
    THE SPANNER TEMPORARY PROSTATIC STENT
    PMA Number
    P060010
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    NZC
    Generic Name
    Stent, urethral, prostatic, semi-permanent
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 9, 2009
    Date Received
    October 16, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE DESIGN OF THE DISTAL ANCHOR INCLUDING MOLDING THE ANCHOR FLAT, REPLACING THE WIRE REINFORCEMENT WITH AN INCREASE IN DUROMETER OF THE SILICONE, AND ADDING TITANIUM DIOXIDE AS A WHITE COLORANT.

    Classifications

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

    Product Code Device Name
    NZC Stent, Urethral, Prostatic, Semi-Permanent