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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 TC CARDIAC ABLATION SYSTEM WITH TEMPERATURE CONTROL
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp.
150 baytech drive
san jose, CA 95134
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/material
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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