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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.
 
DeviceMEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS
Classification Namepacemaker/icd/crt non-implanted components
Generic Namepacemaker/icd/crt non-implanted components
Applicant
Medtronic, Inc.
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP890003
Supplement NumberS283
Date Received08/06/2013
Decision Date10/07/2013
Product Code
OSR[ Registered Establishments with OSR ]
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 A FIRMWARE UPDATE TO THE MODEL 2490C CARELINK REMOTE HOME MONITOR FOR THE DEVICES.
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