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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.
 
DeviceCONCERTO MODEL C154DWK IMPLANTABLE DEVICES
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS058
Date Received11/28/2006
Decision Date02/15/2007
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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