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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC CONSULTA CRT-D D204TRM, MAXIMO II CRT-D D264TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
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/material
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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