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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.
 
Trade NameCHILLI COOLED ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecooled rf ablation system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP990054
Supplement NumberS001
Date Received01/05/2001
Decision Date02/15/2001
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an accelerated aging protocol to be used to extend the shelf life of the approved devices.
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