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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 MODELS C154DWK / C164AWK CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
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 NumberS064
Date Received02/28/2007
Decision Date05/04/2007
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR UPDATES TO THE CARELINK V1.1 DEVICE DATA MANAGEMENT APPLICATION TO (1) PROVIDE SUPPORT FOR CONCERTO WITH ATRIAL THERAPIES; (2) ALLOW TRANSMISSION OF AN ?ALERT? SIGNAL FOR AT/AF BURDEN AND FAST V RESPONSE OBSERVATIONS IF THERE IS AN ASSOCIATED ALERT; (3) OUTPUT THE TYPE OF EPISODE LOG FOR INVALID EPISODES SO CARELINK CAN PROPERLY DISPLAY INVALID EPISODES AS ARRHYTHMIA EPISODES OR VENTRICULAR SENSING EPISODES; AND (4) CORRECT A PROBLEM WHERE THE CARDIAC COMPASS ?VENTRICULAR RATE DURING AT/AF? GRAPH DOES NOT ALWAYS PRINT THE MEAN VENTRICULAR RATE.
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