BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P240013 · Supplement: S024 · Decision Apr 21, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
    Trade Name
    Sphere-9 Catheter
    PMA Number
    P240013
    Supplement Number
    S024
    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
    April 21, 2026
    Date Received
    March 24, 2026
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    the addition of a new warning/precaution statement to the Sphere-9 catheter instructions for use to enhance safety

    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