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

    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

    PMA: P230035 · Supplement: S007 · Decision Oct 24, 2025
    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
    S007
    Device Class
    FDA Class 3
    Product Code
    OOB
    Generic Name
    Drug-eluting percutaneous transluminal coronary angioplasty catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 24, 2025
    Date Received
    September 26, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    combine the Ranger and Agent products into one sampling plan, change the batch definition to a week’s production and to test pre-sterilized devices for endotoxin

    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