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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameNAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
Classification Namecardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP040036
Date Received08/19/2004
Decision Date08/11/2006
Product Code
LPB[ Registered Establishments with LPB ]
Docket Number 06M-0374
Notice Date 09/12/2006
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product 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).
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S013 S014 S015 S016 S017 S019 S020 S021 S022 
S023 S024 S026 S027 S028 S029 S030 S031 S033 
S035 S036 S037 S038 S039 S040 S041 
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