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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.
 
DeviceAurora EV-ICD System
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. NE
Mv Mv S11
Mounds View, MN 55112
PMA NumberP220012
Supplement NumberS054
Date Received06/13/2025
Decision Date09/11/2025
Product Codes LWS NVY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
firmware updates (RAMware) to the Aurora EV-ICD device dynamic sensing algorithm and a new programming application for the CareLink SmartSync programming system to support the Auora EV-ICD device
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