BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P980003 · Supplement: S025 · Decision Apr 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    CHILLI COOLED ABLATION SYSTEM
    PMA Number
    P980003
    Supplement Number
    S025
    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
    April 8, 2011
    Date Received
    October 18, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TEN DESIGN CHANGES TO THE CIRCUCOOL MODEL 8005 PUMP SYSTEM TO ADDRESS STOPPAGE AND MOTOR NOISE COMPLAINTS. THESE CHANGES INCLUDE: 1) CHANGING A SCHOTKY DIODE FROM ON SEMICONDUCTOR¿S 1N5822 (40V MAXIMUM REVERSE VOLTAGE) TO ON SEMICONDUCTOR¿S MBR360 (60V MAXIMUM REVERSE VOLTAGE). 2) ADDITION OF A 33.3V VOLTAGE SUPPRESSOR (ON SEMICONDUCTOR P6KE39AG) ACROSS MOTOR TERMINALS AT THE MOTOR. 3) DIMENSIONAL AND TOLERANCE REVISIONS TO THE ROLLER SLEEVE, SHAFT ROTOR AND ROLLER COMPONENTS.

    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