BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    PMA: P100046 · Decision Dec 14, 2011
    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
    ATRICURE SYNERGY ABLATION SYSTEM
    PMA Number
    P100046
    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
    December 14, 2011
    Date Received
    December 23, 2010
    Expedited Review
    Y
    Docket Number
    11M-0910

    Advisory Committee Statement

    APPROVAL FOR THE ATRICURE SYNERGY ABLATION SYSTEM. THIS DEVICE IS INDICATED FOR THE ABLATION OF CARDIAC TISSUE FOR THETREATMENT OF PERSISTENT ATRIAL FIBRILLATION (SUSTAINED BEYOND SEVEN DAYS, OR LASTING LESS THAN SEVEN DAYS BUT NECESSITATING PHARMACOLOGIC OR ELECTRICAL CARDIOVERSION) OR LONGSTANDING PERSISTENT ATRIALFIBRILLATION (CONTINUOUS ATRIAL FIBRILLATION OF GREATER THAN ONE YEAR DURATION) IN PATIENTS WHO ARE UNDERGOING OPEN CONCOMITANT CORONARY ARTERY BYPASS GRAFTING AND/OR VALVE REPLACEMENT OR REPAIR.

    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