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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameEN TRUST, VIRTUSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, SECURA, VIRTUOSO II, INSYNC MARQUIS, PROTECTA DR,XT, DR, PROT
Classification Nameimplantable cardioverter defibrillator (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS472
Date Received03/18/2014
Decision Date05/16/2014
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for firmware updates (version cm2490g_15v6) to the carelink monitor model 2490g carelink home monitors, model 2020a cardiosight reader, and model 2020b carelink express for a variety of implanted devices.
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