PMA · Cardiovascular

Aurora EV ICD (DVEA3E4)

by Medtronic, Inc.

Aurora EV ICD (DVEA3E4) is an AI-enabled medical device from Medtronic, Inc. that the U.S. FDA approved through PMA P220012/S059 on October 28, 2025. Its lead review panel is Cardiovascular and its primary product code is LWS.

See also FDA-cleared AI cardiovascular devices in 2025, all FDA AI clearances in 2025, top cardiovascular AI devices.

Key facts

Submission numberP220012/S059
PathwayPMA
Date of final decision
Company (FDA list)Medtronic, Inc.
Lead review panelCardiovascular
Primary product codeLWS

Source: FDA AI-Enabled Medical Devices list. No matching openFDA record was found for this submission yet.

What this means

Premarket Approval (PMA) is FDA's most stringent pathway, used for Class III devices. It requires valid scientific evidence of safety and effectiveness. Aurora EV ICD (DVEA3E4) went through this pathway (P220012/S059).

Product code LWS covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Medtronic, Inc. has 7 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

Similar devices (product code LWS)

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