BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P060019 · Supplement: S035 · Decision Feb 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP AND THERAPY COOL PATH SP ABLATION CATHETERS, AND 1500T9-CP RF GENERATORS
    PMA Number
    P060019
    Supplement Number
    S035
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 18, 2016
    Date Received
    November 20, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for software fixes and enhancements for the Ampere RF generator, including file system modifications, system log changes, and revised communication to compatible recording systems and the Cool Point Irrigation Pump.

    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