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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 NameMEDTRONIC MODELS 2490H CARELINK REMOTE HOME MONITOR, 2020C CARELINK EXPRESS MONITOR, AND 2491 DDMA
Classification Namepulse generator, permanent, implantable
ApplicantMEDTRONIC, INC.
PMA NumberP890003
Supplement NumberS319
Date Received08/20/2014
Decision Date11/07/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an update to your carelink and carelink express monitor firmware and software to improve the superimposed dual egm reporting.
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