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

    Catheter, Balloon, Urethral, Drug-Coated

    PMA: P210020 · Supplement: S008 · Decision Apr 25, 2023
    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
    S008
    Device Class
    FDA Class 3
    Product Code
    QRH
    Generic Name
    Catheter, Balloon, Urethral, Drug-Coated
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 25, 2023
    Date Received
    April 3, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Changes to balloon catheter hub bonding process, acceptable quality level for receiving inspection, and leak test maximum delivered pressure.

    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