BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Balloon, Urethral, Drug-Coated

    PMA: P210020 · Supplement: S010 · Decision Jun 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Catheter, Balloon, Urethral, Drug-Coated
    Trade Name
    Optilume Urethral Drug Coated Balloon Catheter
    PMA Number
    P210020
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    QRH
    Generic Name
    Catheter, Balloon, Urethral, Drug-Coated
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 23, 2025
    Date Received
    December 16, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for packaging the Optilume Urethral DCB with the Optilume Basic Urological Balloon Dilation Catheter and Atrion Medical QL inflation device into a kit, an additional site to package the proposed kit, and a labeling change to remove the vascular meta-analysis information from the Instruction for Use.

    Classifications

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

    Product Code Device Name
    QRH Catheter, Balloon, Urethral, Drug-Coated