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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 NumberS003
Date Received12/26/2001
Decision Date01/08/2002
Withdrawal Date 07/28/2006
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC CORPORATION, SAN JOSE, CALIFORNIA.
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