BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    PMA: P200002 · Supplement: S014 · Decision May 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
    Trade Name
    EPi-Sense and EPi-Sense ST Guided Coagulation System
    PMA Number
    P200002
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    OCM
    Generic Name
    Surgical cardiac ablation device, for treatment of atrial fibrillation
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 6, 2026
    Date Received
    April 9, 2026
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for labeling changes intended to enhance the safe use of the device

    Classifications

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

    Product Code Device Name
    OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation