BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    PMA: P030031 · Supplement: S011 · Decision Feb 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61

    Basic Information

    Device Name
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
    Trade Name
    NAVISTAR & CELSIUS THERMOCOOL CATHETERS
    PMA Number
    P030031
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    OAE
    Generic Name
    Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 6, 2009
    Date Received
    August 13, 2008
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    Y
    Docket Number
    09M-0071

    Advisory Committee Statement

    APPROVAL FOR THE NAVISTAR THERMOCOOL CATHETER AND EZ STEER THERMOCOOL CATHETER-NAV VERSION. THESEDEVICES ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING ANDRECORDING), AND WHEN USED WITH THE STOCKERT 70 GENERATOR, FOR THE TREATMENT OF:1) TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER.2) RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA(VT) DUE TO PRIOR MYOCARDIAL INFARCTION (MI) IN ADULTS.3) DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED WITH COMPATIBLE THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEMS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation