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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceCHILLI COOLED ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp.
150 baytech drive
san jose, CA 95134
PMA NumberP980003
Supplement NumberS041
Date Received09/09/2013
Decision Date10/07/2013
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for iec 60601-1 3rd edition labeling implementation to the blazer ii, blazer ii xp/htd, blazer prime xp/htd and chilli ii cardiac ablation catheters and cables.
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