BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Balloon, Urethral, Drug-Coated

    PMA: P210020 · Supplement: S004 · Decision May 17, 2022
    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
    PMA Number
    P210020
    Supplement Number
    S004
    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
    May 17, 2022
    Date Received
    February 24, 2022
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for validation of a new Low EO sterilization cycle utilizing a lower ethylene oxide (EO) concentration and lower EO dwell time.

    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