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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 NameVIRTUOSO DR/VR/ENTRUST DR/VR/MAXIMO DR/VR/INTRINSIC DR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS135
Date Received06/09/2008
Decision Date08/28/2008
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the rv lead integrity alert (rvlia) feature and model sw012, version 1. 0, rvlia software.
Post-Approval StudyShow Report Schedule and Study Progress
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