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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.
Classification Namecardiac ablation percutaneous catheter
Generic Namecooled rf ablation system
PMA NumberP990054
Date Received09/20/1999
Decision Date03/17/2000
Withdrawal Date 07/28/2006
Product Code
LPB[ Registered Establishments with LPB ]
Docket Number 00M-1517
Notice Date 09/26/2000
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
The chilli cooled ablation system is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, rf ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy. In addition, the chilli catheter with tracking is used with the arrhythmia mapping and tracking system to provide catheter location information.
Approval Order Approval Order
Supplements: S001 S003 S004 S005 S006 S007 S008