PMA - Premarket Approval

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New Search Back to Search Results Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.   Trade Name NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER Classification Name cardiac ablation percutaneous catheter Applicant BIOSENSE WEBSTER, INC. PMA Number P040036 Date Received 08/19/2004 Decision Date 08/11/2006 Product Code LPB [ Registered Establishments with LPB ] Docket Number 06M-0374 Notice Date 09/12/2006 Advisory Committee Cardiovascular Expedited Review Granted? No Information About: Labeling, Approval Order, Summary of Safety and Effectiveness Approval Order Statement  Approval for the navistar thermocool deflectable diagnostic/ablation catheters which include models n175tbh, n175tch, n175tdh, n175tfh, n175tcbh, n175tcch, n175tcdh, n175tcfh, and n175tcjh. The navistar thermocool diagnostic/ablation deflectable tip catheter and related accessory devices, when used with the stockert 70 radiofrequency (rf) generator, are indicated for the treatment of recurrent drug/device refractory sustained monomorphic ventricular tachycardia (vt) due to prior myocardial infarction (mi) in adults. The navistar thermocool catheter provides location information when used with the carto ep / xp navigation system, and can be used for catheter-based cardiac electrophysiological mapping (stimulation and recording). Post-Approval Study Show Report Schedule and Study Progress Supplements: S001 S002 S003 S004 S005 S006  S007 S008 S009