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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 NameSECURA DR/VR MAXIMO II DR/VR AND VIRTUOSO II DR/VR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS164
Date Received10/22/2008
Decision Date03/31/2009
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Clinical Trials NCT00279279
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 model 9995 v1. 2 application software which includes the lead integrity alert feature and additional software updates.
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