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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.
 
DeviceAdvisa DR MRI SureScan Model A2DR01 IPG, Advisa SR MRI SureScan Model A3SR01 IPG
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS721
Date Received06/17/2022
Decision Date08/26/2022
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for addition of the summary for your Post Approval Study, Pacing Capture Threshold (PCT) Change Following 3T MRI Scan of MR Conditional CIEDs, to the labeling.
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