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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 AND CHILLI RPM COOLED ABLATION SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
2710 Orchard Pkwy.
San Jose, CA 95113
PMA NumberP990054
Supplement NumberS005
Date Received10/02/2003
Decision Date02/09/2004
Withdrawal Date07/28/2006
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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