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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.
 
DeviceENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II SECURA/VIRTUOSO II/INSYNC MARQUIS/VIRTUOSO/PROTECTA
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980016
Supplement NumberS327
Date Received11/10/2011
Decision Date12/06/2011
Product Code LWS 
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 FOR FIRMWARE UPDATES TO THE MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A MEDTRONIC CARDIOSIGHT READER AND MODEL 2020B CARELINK EXPRESS MONITOR.
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