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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 AND CHILLI RPM COOLED ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecooled rf ablation system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP990054
Supplement NumberS006
Date Received11/03/2003
Decision Date12/31/2003
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a sterilization facility located at cosmed of rhode island, inc. , coventry, rhode island.
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