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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 RPM CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Namecooled rf ablation system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP990054
Supplement NumberS008
Date Received05/16/2006
Decision Date06/13/2006
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate biological indicator (bi) supplier.
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