Aurora EV ICD (DVEA3E4) is an AI-enabled medical device from Medtronic, Inc., listed by FDA (PMA supplement, P220012/S059) with a decision date of 2025-10-28. Review panel: Cardiovascular.
| FDA submission number | P220012/S059 |
|---|---|
| Pathway | PMA supplement |
| Company | Medtronic, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-10-28 |
| Product code | LWS |
| Classification | Implantable Cardioverter Defibrillator (Non-Crt) |
| Device class | 3 |
| Review time (calendar days) | 29 |
Official FDA database record · FDA AI-enabled device list
More devices from Medtronic, Inc. · All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.