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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 II Cooled Catheter, Sterile Cables, Tubing Kit
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp.
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP980003
Supplement NumberS093
Date Received01/28/2022
Decision Date02/25/2022
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Introduction of parametric release for the BSC2000-2 Ethylene Oxide Sterilization Cycle at the BSC Coventry, RI Facility.
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