BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

    PMA: P230035 · Supplement: S006 · Decision Feb 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
    Trade Name
    AGENT Paclitaxel-Coated Balloon Catheter
    PMA Number
    P230035
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    OOB
    Generic Name
    Drug-eluting percutaneous transluminal coronary angioplasty catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 11, 2026
    Date Received
    May 22, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a manufacturing site change to include Boston Scientific Ltd., located at Ballybrit Business Park, Galway, Ireland, for drug coating manufacturing, packaging and labeling for the Agent Monorail Paclitaxel Coated Balloon Catheter

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OOB Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter