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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 NameMAXIMO II DR,MAXIMO II VR,VIRTUOSO II VR,SECURA DR,SECURA VR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS452
Date Received12/18/2013
Decision Date07/09/2014
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 medtronic viva crt-p model c6tr01 implantable pacemaker with cardiac resynchronization; programmer software application model 9995 v8. 3; and updates to the medtronic carelink monitor model 2490g, cardiosight reader model 2020a and carelink express model 2020b firmware, and to the model 2491 device data management application (ddma).
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