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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 ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVBC3D4 Evera XT VR ICD DVBB1D4 M
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 NumberS955
Date Received03/30/2026
Decision Date06/25/2026
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a material change in the pulse generator header components of the Blackwell and Aurora device families, updates to the connector stiffness test method, and relocation of incoming inspection activities
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