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

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    PMA: P200002 · Supplement: S006 · Decision May 25, 2023
    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 ST RF Cable
    PMA Number
    P200002
    Supplement Number
    S006
    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
    May 25, 2023
    Date Received
    April 28, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Expansion of the current manufacturing campus for the CSK-2060 to include an additional building located at 7555B Innovation Way, Mason, OH 45040 and an update to a pouch sealing test method.

    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