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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.
 
DeviceEPT-1000 CARDIAC ABLATION SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp.
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP920047
Supplement NumberS015
Date Received11/07/2001
Decision Date04/18/2002
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR NEW INDICATIONS FOR USE FOR ONE DEVICE COMPONENT OF THE EPT-1000 CARDIAC ABLATION SYSTEM. THE DEVICE COMPONENT, AS MODIFIED, WILL, BE MARKETED UNDER THE TRADE NAME EPT-1000 TC CARDIAC ABLATION CONTROLLER WITH TEMPERATURE CONTROL AND IS INDICATED FOR USE IN CONJUNCTION WITH THE APPROPRIATE RADIOFREQUENCY ABLATION CATHETER FOR CARDIAC ABLATION PROCEDURES.
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