BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P990054 · Supplement: S005 · Decision Feb 9, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    CHILLI AND CHILLI RPM COOLED ABLATION SYSTEM
    PMA Number
    P990054
    Supplement Number
    S005
    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 9, 2004
    Date Received
    October 2, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF THE CHILLI AND CHILLI RPM CATHETERS WITH THE EPT-1000 XP RF GENERATOR USING THE SAME MAXIMUM OUTPUT POWER AS THAT USED WITH THE MODEL 8004 AND EPT-1000 TC GENERATORS.

    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