| 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. |
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| Trade Name | NAVISTAR & CELSIUS THERMOCOOL CATHETERS |
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| Classification Name | catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
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| Generic Name | radiofrequency ablation catheter, electrode recording catheter |
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| Applicant | BIOSENSE WEBSTER, INC. |
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| PMA Number | P030031 |
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| Supplement Number | S011 |
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| Date Received | 08/13/2008 |
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| Decision Date | 02/06/2009 |
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| Product Code | |
| Docket Number | 09M-0071 |
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| Notice Date | 02/18/2009 |
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| Advisory Committee |
Cardiovascular |
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| Supplement Type | panel track |
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| Supplement Reason | labeling change - indications |
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| Expedited Review Granted? | Yes |
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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. |
| Post-Approval Study | Show Report Schedule and Study Progress |
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