BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Prostatic, Semi-Permanent

    PMA: P060010 · Supplement: S013 · Decision Oct 7, 2022
    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
    S013
    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
    October 7, 2022
    Date Received
    June 22, 2020
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    22M-2543

    Advisory Committee Statement

    Approval for the Spanner Prostatic Stent. The device is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination for patients who are not candidates for pharmacologic, minimally invasive or surgical treatment of the prostate.

    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