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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/CONCERTO II/CONSULTA DF4/CONSULTA/INSYNC II PROTECT/INSYNC III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/INSYNC II MA
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 NumberS553
Date Received06/01/2016
Decision Date08/07/2016
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a web-based battery longevity estimation tool for ICD and CRT-D devices and updates to the existing battery longevity estimation tools.
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