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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
3333 diamond canyon rd.
diamond bar, CA 91765
PMA NumberP030031
Supplement NumberS011
Date Received08/13/2008
Decision Date02/06/2009
Product Code
OAE[ Registered Establishments with OAE ]
Docket Number 09M-0071
Notice Date 02/18/2009
Advisory Committee Cardiovascular
Clinical Trials NCT00116428
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination Product No
Approval Order 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress