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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 CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
150 Baytech Dr.
San Jose, CA 95134
PMA NumberP980003
Supplement NumberS029
Date Received06/09/2011
Decision Date07/19/2011
Withdrawal Date02/28/2024
Product Code LPB 
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR PACKAGING DESIGN CHANGE FOR THE BLAZER II/PRIME HTD CATHETERS ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510; CHILLI COOLED ABLATION SYSTEM ELECTROPHYSIOLOGY CABLES, MODELS M0046810 AND M004620620; AND BLAZER II XP AND BLAZER PRIME CARDIAC ABLATION CATHETERS ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510.
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