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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.
 
DeviceINSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO & VIRTUOSO CRT-ICDS
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 NumberS061
Date Received12/20/2006
Decision Date01/30/2007
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 THE MEDTRONIC MODELS 2490G (REV. T APPLICATION SOFTWARE VERSION 5V3); MEDTRONIC 2020A CARDIOSIGHT READER (APPLICATION SOFTWARE VERSION 5V3); AND MEDTRONIC 2491 DDMA SOFTWARE. THE MEDTRONIC 2491 DDMA SOFTWARE CONTAINS THE XML TRANSLATION UTILITY (XMLTU) SOFTWARE VERSION V17, THE PRESENTING WAVEFORM UTILITY (PWF) SOFTWARE VERSION 16V1, AND THE SESSION DATA DECODE (SDD) SOFTWARE VERSION 1V2.
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