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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.
 
DeviceCHILI/CHILI II COOLED ABLATION SYSTEM AND CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
150 Baytech Dr.
San Jose, CA 95134
PMA NumberP980003
Supplement NumberS022
Date Received01/26/2010
Decision Date02/22/2010
Withdrawal Date02/28/2024
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
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