BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Prostatic, Semi-Permanent

    PMA: P060010 · Decision Dec 14, 2006
    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
    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 14, 2006
    Date Received
    March 14, 2006
    Expedited Review
    N
    Docket Number
    06M-0529

    Advisory Committee Statement

    APPROVAL FOR THE SPANNER TEMPORARY PROSTATIC STENT. THE DEVICE IS INTENDED FOR TEMPORARY USE (UP TO 30 DAYS) TO MAINTAIN URINE FLOW AND ALLOW VOLUNTARY URINATION IN PATIENTS FOLLOWING MINIMALLY INVASIVE TREATMENT FOR BENIGN PROSTATIC HYPERPLASIA (BPH) AND AFTER INITIAL POST-TREATMENT CATHETERIZATION.

    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