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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 TC CARDIAC ABLATION SYSTEM WITH TEMPERATURE CONTROL
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation
ApplicantEP TECHNOLOGIES, INC.
PMA NumberP920047
Supplement NumberS001
Date Received11/17/1994
Decision Date11/08/1995
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 an alternate configuration of the ept-1000 cardiac ablation controller which incorporates a temperature control feature.
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