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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 NameCONCERTO MODEL C154DWK IMPLANTABLE DEVICES
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
ApplicantMEDTRONIC VASCULAR
PMA NumberP010031
Supplement NumberS058
Date Received12/14/2006
Decision Date02/15/2007
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for firmware updates to 1) address a ?soft? rate limit power on reset, 2) load a temperature sensitivity update at the time of manufacturing, and 3) load optivol enhancements (for use outside of the united states only) at the time of manufacturing.
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