BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

    PMA: P250007 · Decision Dec 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stent, Urethral, Prostatic, Permanent Or Semi-Permanent
    Trade Name
    Zenflow Spring® Implant and Delivery System
    PMA Number
    P250007
    Device Class
    FDA Class 3
    Product Code
    MER
    Generic Name
    STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 11, 2025
    Date Received
    March 11, 2025
    Expedited Review
    N
    Docket Number
    FDA-7228

    Advisory Committee Statement

    The Zenflow Spring Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25 and 45 mm and prostate sizes between 25 and 80 cc.

    Classifications

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

    Product Code Device Name
    MER Stent, Urethral, Prostatic, Permanent Or Semi-Permanent