# P220012: Aurora EV-ICD System

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Oct 20, 2023 after 434 days
- Product code: LWS (Implantable Cardioverter Defibrillator (Non-Crt))
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 29, 2025 · Class II · Z-0726-2026: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

Source page: https://510kreport.com/device/P220012
Methodology: https://510kreport.com/methodology