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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 II COOLED ABLATION CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Namerf ablation system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP980003
Supplement NumberS015
Date Received03/16/2005
Decision Date05/20/2005
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 extension of the shelf life from six (6) months to on (1) year; and, packaging changes for the chilli ii ablation catheter.
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