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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 NumberS019
Date Received05/10/2007
Decision Date07/24/2007
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extension of the expiration date (shelf-life) from one-year to three-years for the chilli ii cardiac ablation catheter.
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