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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 NameMEDTRONIC CONSULTA & MAXIMO ICDS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS096
Date Received04/10/2008
Decision Date07/11/2008
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the inc. 3 ramware, which contains a design change to address an issue with the l409 integrated circuit (ic) in the consulta crt-d d224trk, maximo ii crt-d d284trk implantable cardioverter defibrillators with cardiac resynchronization, secura dr d224drg and secura vr d224vrc, maximo ii dr d284drg and maximo ii vr d284vrc implantable cardioverter defibrillators.
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