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

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    PMA: P220029 · Supplement: S004 · Decision Dec 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia
    Trade Name
    Optilume™ BPH Catheter System
    PMA Number
    P220029
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    QXB
    Generic Name
    Drug coated prostatic dilation catheter for benign prostatic hyperplasia
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 12, 2025
    Date Received
    November 25, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change of an additional pre-dilation catheter supplier manufacturing site

    Classifications

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

    Product Code Device Name
    QXB Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia