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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCHILLI II COOLED ABLATION CATHETERS
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
150 Baytech Dr.
San Jose, CA 95134
PMA NumberP980003
Supplement NumberS007
Date Received05/14/2003
Decision Date09/02/2003
Withdrawal Date02/28/2024
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE CHILLI II COOLED ABLATION CATHETER. THE DEVICE IS INDICATED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING; DELIVERY DIAGNOSTIC PACING STIMULI; AND RADIOFREQUENCY ABLATION OF MAPPABLE VENTRICULAR TACHYCARDIAS ATTRIBUTABLE TO ISCHEMIC HEART DISEASE OR CARDIOMYOPATHY IN PATIENTS WHO HAVE FAILED DRUG THERAPY.
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