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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
ApplicantEP TECHNOLOGIES, INC.
PMA NumberP920047
Supplement NumberS014
Date Received03/26/2001
Decision Date04/24/2001
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes in the manufacturing operation: a change in the welding process from a manual to an automated process, a change in the grit blast media, and removal of a chemical to the weld joint.
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