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

    Catheter, Balloon, Urethral, Drug-Coated

    PMA: P210020 · Supplement: S009 · Decision Jan 13, 2024
    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
    S009
    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
    January 13, 2024
    Date Received
    December 8, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to implement an additional Confluent Medical catheter manufacturing site in Costa Rica

    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