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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 CRT-D D204TRM, MAXIMO II CRT-D D264TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS176
Date Received12/04/2009
Decision Date01/09/2012
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for the df4 connector system, which is comprised of the icd, crt-d and defibrillation lead devices for the devices.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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