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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 NumberS012
Date Received01/14/2004
Decision Date02/09/2004
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Four manufacturing changes: 1) change to cooling lumen extrusion; 2) change to flux cleaning process; 3) change from 1x to 2x kevlar wrap; and 4) change from molded to machined distal ring electrode grooves.
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