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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.
 
DeviceCARELINK MONITOR MODEL 2490C, MODEL 2491 DDMA AND CARDIOSIGHT READER MODEL 2020A
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS150
Date Received09/26/2008
Decision Date10/21/2008
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
Approval Order Statement  
APPROVAL TO IMPLEMENT A DESIGN CHANGE TO USE MODELS 2490C MEDTRONIC CARELINK MONITOR, 2020A CARDIOSIGHT READER, AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) TO PROVIDE PATIENTS AND DATA TRANSFER FOR THE CONCERTO II MODEL CRT-D D274TRK, VIRTUOSO II ICD MODEL DR D274DRG AND MODEL VR D274VRC DEVICES.
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