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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 II CRT-D MODELS C154DWK, C164AWK
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP010031
Supplement NumberS126
Date Received09/26/2008
Decision Date10/21/2008
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO IMPLEMENT A DESIGN CHANGE TO USE MODELS 2490C MEDTRONIC CARELINK MONITOR, 2020A CARDIOSIGHT READER, AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) TO PROVIDE PATIENTS AND DATA TRANSFER FOR THE CONCERTO II MODEL CRT-D D274TRK, VIRTUOSO II ICD MODEL DR D274DRG AND MODEL VR D274VRC DEVICES.
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