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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, SECURA & VIRTUOSO II DR/VR ICDS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS343
Date Received03/07/2012
Decision Date06/04/2012
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
Review Memo Review Memo
Approval Order Statement 
Approval for maximo ii icd models d264drm, d284drg, d284vrc; secura icd models d204drm, d224drg, d224vrc; and virtuoso ii dr/vr icd models d274drg and d274vrc.
Approval Order Approval Order
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