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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 NumberS013
Date Received08/30/2004
Decision Date10/14/2004
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes made to the internal distal tip configuration and the catheter shaft as well as changes in the manufacturing process to bond the steering mechanism to the braided shaft for the chilli ii cardiac ablation catheter.
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