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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 NameCOGNIS CARDIAC RESYNCHRONIZATION HIGH ENERGY DEFIBRILLATOR
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS179
Date Received04/30/2008
Decision Date05/08/2008
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for updates to the programmer sw model 2868 v1. 02 and pulse generator firmware v1. 04. 0, patch v1. 00 for the teligen and cognis families of devices.
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