|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 Name||THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM|
|Classification Name||cardiac ablation percutaneous catheter|
|Applicant||BIOSENSE WEBSTER, INC.|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of force sensing technology to the catheter tip. The device, as modified, will be marketed under the trade name thermocool smarttouch catheter and is indicated for: the biosense webster thermocool smarttouch navigation catheter and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible rf 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; and 3) drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The thermocool smarttouch navigation catheter provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with carto 3 navigation system.