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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 NumberS020
Date Received03/25/2024
Decision Date04/24/2024
Product Codes LWS NVY 
Advisory Committee Cardiovascular
Clinical TrialsNCT06048731
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
of the revised protocol for the Enlighten post-approval study (PAS). The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220012
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