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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 MONITOR AND CARDIOSIGHT READER
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP890003
Supplement NumberS141
Date Received06/13/2008
Decision Date07/08/2008
Product Code NVZ 
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 THE CHANGES MADE TO THE MODEL 2490G MEDTRONIC CARELINK MONITOR, MODEL 2020A CARDIOSIGHT READER AND MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AS FOLLOWS: 1) UPDATED FIRMWARE IN THE MODEL 2490G CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER TO PROVIDE PATIENT AND DEVICE DATA TRANSFER FROM THE REVEAL XT AND REVEAL DX TO THE MODEL 2490G CARELINK MONITOR.2) UPDATED FIRMWARE IN THE MODEL 2490G CARELINK MONITOR TO ALLOW THE MONITOR TO FACILITATE RESETTING FIVE OF THE EIGHT NOTIFICATIONS OF THE MODEL 9529 REVEAL XT USED IN CONJUNCTION WITH THE MODEL 9539 REVEAL PATIENT ASSISTANT.3) UPDATED FIRMWARE IN THE MODEL 2490G CARELINK MONITOR AS A PREVENTATIVE MEASURE, TO RESOLVE AN INCONSISTENCY WHICH COULD POTENTIALLY CAUSE AN INVALID CARELINK TRANSMISSION TO BE SENT TO THE CARELINK NETWORK. 4) UPDATED THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) TO SUPPORT THE MODEL 9529 REVEAL XT AND THE MODEL 9528 REVEAL DX INSERTABLE CARDIAC MONITORS.
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