BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    PMA: P240013 · Supplement: S013 · Decision Aug 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
    Trade Name
    HexaGen™ RF Generator, HexaPulse™ PF Generator, HexaFlow™ Irrigation Pump
    PMA Number
    P240013
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    QZI
    Generic Name
    Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 15, 2025
    Date Received
    June 25, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a manufacturing site located at Plexus Inc., 2400 Millbrook Dr., Buffalo Grove, IL 60089 (FEI: 3004105270)

    Classifications

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

    Product Code Device Name
    QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation