BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    PMA: P200002 · Decision Apr 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
    Trade Name
    EPi-Sense Guided Coagulation System
    PMA Number
    P200002
    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
    April 28, 2021
    Date Received
    January 2, 2020
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the EPi-Sense Guided Coagulation System is intended for the treatment of symptomatic long-standing persistent atrial fibrillation (continuous atrial fibrillation greater than 12 months duration) when augmented in a hybrid procedure with an endocardial catheter listed in the instructions for use, in patients who are refractory or intolerant to at least one Class I and/or III antiarrhythmic drug (AAD); and, in whom the expected benefit from rhythm control outweighs the potential known risks associated with a hybrid procedure such as delayed post-procedure inflammatory pericardial effusions.

    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