Product code

AI devices with FDA product code LWS

Product code LWS covers 2 devices on the FDA AI-enabled list, from 2 companies. Most are reviewed by the Cardiovascular panel (2). The most recent decision was Aurora EV ICD (DVEA3E4) on October 28, 2025.

2AI devices

2Companies

2025First decision

2025-10-28Latest decision

Trend: devices per year

2025

AI devices with FDA product code LWS per year: 2025 2

Top companies

Medtronic, Inc.1
Medtronic Cardiac Rhythm Disease Management1

All 2 devices, newest first

Aurora EV ICD (DVEA3E4)Medtronic, Inc. · CardiovascularP220012/S0592025-10-28
Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI IMedtronic Cardiac Rhythm Disease Management · CardiovascularP980016/S9392025-10-28