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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.
2710 ORCHARD PKWY.
SAN JOSE, CA 95113
PMA NumberP990054
Supplement NumberS001
Date Received01/05/2001
Decision Date02/15/2001
Withdrawal Date 07/28/2006
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ACCELERATED AGING PROTOCOL TO BE USED TO EXTEND THE SHELF LIFE OF THE APPROVED DEVICES.
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