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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 CARELINK EXPRESS MONITORS, MODIFICATIONS T THE MEDTRONIC CARELINK REMOTE HOME MONITOR AND MEDTRONIC CARDIOSIGH
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS228
Date Received05/25/2011
Decision Date08/25/2011
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MODELS 2020B/C MEDTRONIC CARELINK EXPRESS MONITORS AND MODIFICATIONS TO THE MODEL 2490/G/H/J MEDTRONIC CARELINK REMOTE HOME MONITOR AND MODEL 2020A MEDTRONIC CARDIOSIGHT READER TO UPDATE DEVICE FIRMWARE.
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