BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    PMA: P220029 · Decision Jun 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia
    Trade Name
    Optilume™ BPH Catheter System
    PMA Number
    P220029
    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
    June 30, 2023
    Date Received
    December 12, 2022
    Expedited Review
    N
    Docket Number
    23M-2744

    Advisory Committee Statement

    Approval for the Optilume BPH Catheter System indicated for the treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH) in men >= 50 years of age.

    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