BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P040036 · Supplement: S002 · Decision Apr 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
    PMA Number
    P040036
    Supplement Number
    S002
    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 23, 2007
    Date Received
    December 1, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MERGING THE LABELING FOR THE TWO APPROVED INDICATIONS FOR THE NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION CATHETERS (ATRIAL FLUTTER UNDER P030031, AND VENTRICULAR TACHYCARDIA UNDER P040036) AND UPDATING THE LABELING FOR THE CELSIUS THERMOCOOL WHICH REMAINS APPROVED FOR TREATMENT OF ATRIAL FLUTTER ONLY.

    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