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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameREVEAL DX. REVEAL XT, REVEAL LINQ INSERTABLE CARDIAC MONITOR
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP890003
Supplement NumberS305
Date Received03/18/2014
Decision Date05/16/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for firmware updates (version cm2490g_15v6) to the carelink monitor model 2490g carelink home monitors, model 2020a cardiosight reader, and model 2020b carelink express for a variety of implanted devices.
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