BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    PMA: P220029 · Supplement: S003 · Decision Dec 15, 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
    S003
    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
    Approved
    Decision Code
    APPR
    Decision Date
    December 15, 2025
    Date Received
    November 17, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the revised protocol for the post-approval study (PAS)

    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