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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.
 
DeviceViva, Brava, Protecta, Protecta XT, Concerto, Concerto II, Consulta, Maximo II, InSync II Protect, Amplia, Compia and Cl
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 NumberS628
Date Received04/17/2018
Decision Date05/30/2018
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 Medtronic MyCareLink Patient Monitor Models 24950 and 24952.
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