BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P040036 · Decision Aug 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
    PMA Number
    P040036
    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
    August 11, 2006
    Date Received
    August 19, 2004
    Expedited Review
    N
    Docket Number
    06M-0374

    Advisory Committee Statement

    APPROVAL FOR THE NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS WHICH INCLUDE MODELS N175TBH, N175TCH, N175TDH, N175TFH, N175TCBH, N175TCCH, N175TCDH, N175TCFH, AND N175TCJH. THE NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORY DEVICES, WHEN USED WITH THE STOCKERT 70 RADIOFREQUENCY (RF) GENERATOR, ARE INDICATED FOR THE TREATMENT OF RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA (VT) DUE TO PRIOR MYOCARDIAL INFARCTION (MI) IN ADULTS.THE NAVISTAR THERMOCOOL CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH THE CARTO EP / XP NAVIGATION SYSTEM, AND CAN BE USED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING).

    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