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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 S035 
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