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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 ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namerf ablation system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP980003
Supplement NumberS008
Date Received06/20/2003
Decision Date08/07/2003
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the post-approval study protocol to allow for the maximum limit of 40 patients or 20 percent of the total study enrollment at any one site.
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