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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 NameMEDTRONIC IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR SYSTEMS ENTRUST ICOS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS058
Date Received10/07/2005
Decision Date11/15/2005
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) medtronic model 2490g carelink monitor, model 2020a cardiosight reader and model 2491 ddma software to support the entrust icds 2) to make optivol information without the threshold line available for insync sentry models 7297 and 7299 viewable by physicians using the carelink network.
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