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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.
Generic Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantMedtronic, Inc
8200 coral sea street ne
mounds view, MN 55112
PMA NumberP090013
Supplement NumberS205
Date Received10/13/2015
Decision Date04/28/2016
Product Codes NVN LWP 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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