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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 COOLED ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecooled rf ablation system
ApplicantCARDIAC PATHWAYS CORP.
PMA NumberP980003
Supplement NumberS002
Date Received04/14/1999
Decision Date05/06/1999
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 hardware and software changes made to support a single board computer, as well as software changes to allow the use of user-selected flow rates for the pump.
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