BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    PMA: P220029 · Supplement: S002 · Decision Aug 15, 2024
    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
    Supplement Number
    S002
    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
    August 15, 2024
    Date Received
    May 21, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change in supplier for two kit components (i.e., the Tuohy-Borst adapter and stopcock), a change in kit packaging of the components (i.e., addition of the Tuohy-Borst adapter and Stopcock to the Pre-Dilation Catheter Tyvek Pouch), and a change in labeling to remove the vascular meta-analysis information from the Instructions for Use

    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