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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
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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