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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Boston Scientific Corp.
150 baytech drive
san jose, CA 95134
PMA NumberP980003
Date Received01/30/1998
Decision Date02/02/1999
Product Code
LPB[ Registered Establishments with LPB ]
Docket Number 99M-2016
Notice Date 06/28/1999
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the Chili(R) Cooled Ablation System which includes: 1)Chili(R) Cooled Ablation Catheter, Standard Curve (Model 3005; 2)Chili(R) Cooled Ablation Catheter, Large Curve (Model 3006); RF Generator/Pump System (Model 8004); EGM Bypass Switch Box (model 2035); RF Filter Box (Model 2048); Chili(R) Tubing Kit (Model 2100); EGM/RF Generator Cable (Models 2001 and 2028); and EGM Generator Cable (Model 2002 and 2029). This device is indicated for cardiac electropysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S024 S025 S026 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S058 
S059 S061 S062 S063 S064 S065 S066 S068 S069 
S071 S072 S073 S074 S075 S076 S077 S078 S079 
S080 S081 S082