BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    PMA: P100046 · Supplement: S009 · Decision Dec 31, 2018
    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
    Synergy Ablation System
    PMA Number
    P100046
    Supplement Number
    S009
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 31, 2018
    Date Received
    December 10, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Expand Atricures current manufacturing site to include an additional building located within close proximity to the current manufacturing facility (within 0.3 miles) to conduct distribution, warehousing, and servicing operations currently conducted in the current facility footprint.

    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