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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.
 
Trade NameCHILLI AND CHILLI RPM COOLED ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecooled rf ablation system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP990054
Supplement NumberS005
Date Received10/10/2003
Decision Date02/09/2004
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the chilli and chilli rpm catheters with the ept-1000 xp rf generator using the same maximum output power as that used with the model 8004 and ept-1000 tc generators.
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