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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 NameEPT-1000 CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
ApplicantEP TECHNOLOGIES, INC.
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
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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