BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Balloon, Urethral, Drug-Coated

    PMA: P210020 · Supplement: S006 · Decision Sep 29, 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
    S006
    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
    September 29, 2022
    Date Received
    August 30, 2022
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the revised protocol for the post-approval study (PAS) protocol.

    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