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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 (DVEA3E4)
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. NE
Mv Mv S11
Mounds View, MN 55112
PMA NumberP220012
Supplement NumberS059
Date Received09/29/2025
Decision Date10/28/2025
Product Codes LWS NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
replacing existing visual inspections with a closed-system artificial intelligence automated visual inspection combined with operator review
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