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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.
 
Trade NameNAVISTAR & CELSIUS THERMOCOOL CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Generic Nameradiofrequency ablation catheter, electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
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
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the navistar thermocool catheter and ez steer thermocool catheter-nav version. These devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording), 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
Post-Approval StudyShow Report Schedule and Study Progress
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