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

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    PMA: P100010 · Supplement: S145 · Decision Mar 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61

    Basic Information

    Device Name
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
    Trade Name
    Arctic Front Advanced Cardiac Cryoablation Catheter, Arctic Front Advanced PRO Cardiac Cryoablation Catheter, 9F Freezor
    PMA Number
    P100010
    Supplement Number
    S145
    Device Class
    FDA Class 3
    Product Code
    OAE
    Generic Name
    Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 29, 2024
    Date Received
    March 1, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    minor manufacturing changes to the Arctic Front Advance (AFA) (2AF234 and 2AF284), Arctic Front Advance Pro (AFA Pro) (AFAPRO23 and AFAPRO28), Freezor (207F1, 207F3, 207F5), Freezor Xtra (217F1, 217F3, 217F5) and Freezor MAX (209F3 and 209F5) cryoablation catheters

    Classifications

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

    Product Code Device Name
    OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation