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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 NumberS016
Date Received11/23/2001
Decision Date12/18/2001
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of a current vendor, memry corporation in bethel, connecticut, to produce steering wire subassemblies currently manufactured in-house at boston scientific corporation.
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