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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 THERAPY-DEFIBRILLATOR, INCEPTA CARDIAC RESYNCHRONICATION THERAPY-DEBIBRILLATOR,ENERGEN
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namecardiac resynchronization therapy-defibrillator
ApplicantMAQUET CARDIOVASCULAR LLC
PMA NumberP010012
Supplement NumberS318
Date Received12/26/2012
Decision Date01/22/2013
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the sputtered ceramic lapping process used during feedthru assembly.
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