BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Prostatic, Semi-Permanent

    PMA: P060010 · Supplement: S010 · Decision Jul 28, 2011
    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
    S010
    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
    July 28, 2011
    Date Received
    May 20, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DESIGN CHANGE TO ADD AN ACCESS TETHER, CALLED THE SHORE LINE TO THE DEVICE.

    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