BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stent, Urethral, Prostatic, Semi-Permanent

    PMA: P060010 · Supplement: S012 · Decision Oct 6, 2014
    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 AND ACCESSORIES
    PMA Number
    P060010
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    NZC
    Generic Name
    Stent, urethral, prostatic, semi-permanent
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 6, 2014
    Date Received
    September 10, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    UTILIZATION OF A LARGER EXISTING CLEANROOM WITHIN THE CURRENT MANUFACTURING FACILITY.

    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