BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P210027 · Supplement: S008 · Decision Nov 15, 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
    TX eco Extension Cable
    PMA Number
    P210027
    Supplement Number
    S008
    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
    Approved
    Decision Code
    APPR
    Decision Date
    November 15, 2024
    Date Received
    March 12, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    an alternate manufacturing site located in Tijuana, Baja California, Mexico (Establishment Registration Number 3008093809) for the TX eco EXT Cable, nMARQ Catheter Interface Cable, and the SmartAblate System Interface Cable

    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