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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 NameE P TECH EPT-1000 CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation
ApplicantEP TECHNOLOGIES, INC.
PMA NumberP920047
Supplement NumberS009
Date Received10/15/1997
Decision Date04/06/1998
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design modifications that provide for new circuitry to an accessory of the system (automatic personality module) which permits filtering of electrograms during ablation.
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