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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
Medtronic, Inc.
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP930039
Supplement NumberS142
Date Received10/13/2015
Decision Date04/28/2016
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the expansion of MRI conditional labeling for the Advisa and Evera SureScan systems to 3T MRI.
Post-Approval StudyShow Report Schedule and Study Progress
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