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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCHILLI COOLED ABLATION SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp.
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP980003
Supplement NumberS008
Date Received06/20/2003
Decision Date08/07/2003
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
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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