Cardiology
Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I
Medtronic Cardiac Rhythm Disease Management
FDA
FDA-cleared AI medical device
These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
FDA Submission Metadata
- Submission number
- P980016/S939
- Decision date
- October 2025
- FDA panel
- Cardiovascular
- Product code
- LWS
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
FDA
US FDA PMA
P980016/S939
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.