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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 MRI SURESCAN LEAD MODEL 5086MRI
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
Medtronic, Inc
8200 coral sea street ne
mounds view, MN 55112
PMA NumberP090013
Supplement NumberS205
Date Received10/13/2015
Decision Date04/28/2016
Product Code
LWP[ Registered Establishments with LWP ]
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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