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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.
 
DeviceEvera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4); Evera S DR
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980016
Supplement NumberS963
Date Received07/15/2026
Decision Date07/31/2026
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to update test methodology and parameters for screening of integrated circuits used in Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators
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