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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
3333 diamond canyon rd.
diamond bar, CA 91765
PMA NumberP990025
Supplement NumberS011
Date Received01/18/2006
Decision Date03/28/2006
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a minor labeling revision for the 4 mm qwikstar diagnostic/ablation catheter to include the noga xp navigation system as an optional mapping system for the qwikstar catheter. The device, as modified, will be marketed under the same trade name and is indicated for catheter-based atrial and ventricular electrophysiological mapping and for use with compatible radio-frequency generators in adults and children four years of age or older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias. When used in the carto xp ep or noga xp navigation systems, the qwikstar diagnostic/ablation catheter provides location information and approximate catheter tip curvature.