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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.
 
DeviceEPT-1000 CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp.
150 baytech drive
san jose, CA 95134
PMA NumberP920047
Supplement NumberS015
Date Received11/07/2001
Decision Date04/18/2002
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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