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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 NumberS013
Date Received11/05/1999
Decision Date11/30/1999
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a change in the manufacturing (sterilization) process for therapeutic ablation catheters used with the ept-1000 that will allow the use of alternate biological indicators with a reduced incubation time.
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