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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 NameEPIC/EPIC+ AND ATLAS/ATLAS+ FAMILY OF PULSE GENERATORS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametranstelephonic follow-up/monitoring system
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS101
Date Received02/15/2006
Decision Date03/14/2006
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change from a manual to an automated system for the soldering of the output flex to feedthru subassemblies on the device.
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