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

    Cardiac Ablation Percutaneous Catheter

    PMA: P040014 · Supplement: S049 · Decision Oct 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    Therapy™ Ablation Catheter (4mm and 8mm), Cables 16- 17- 18- & 19-
    PMA Number
    P040014
    Supplement Number
    S049
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 15, 2024
    Date Received
    September 16, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change to the bioburden alert and action limits used at the Irvine, California manufacturing facility

    Classifications

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

    Product Code Device Name
    LPB Cardiac Ablation Percutaneous Catheter