Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I is an AI-enabled medical device from Medtronic Cardiac Rhythm Disease Management that the U.S. FDA approved through PMA P980016/S939 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 number | P980016/S939 |
|---|---|
| Pathway | PMA |
| Date of final decision | |
| Company (FDA list) | Medtronic Cardiac Rhythm Disease Management |
| Lead review panel | Cardiovascular |
| Primary product code | LWS |
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. Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I went through this pathway (P980016/S939).
Product code LWS covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. Medtronic Cardiac Rhythm Disease Management has 1 AI-enabled device 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.