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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, VIRTUOSO II DR/VR, MAXIMO II DR/VR ICDS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS187
Date Received03/06/2009
Decision Date04/04/2011
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the advisa dr a4dr01 implantable pulse generator, model 9995 application software v7. 3, carelink monitor model 2490g upgrade, cardiosight reader model 2020a upgrade, and model 2491 ddma upgrade.
Approval Order Approval Order
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