Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I

Medtronic Cardiac Rhythm Disease Management · P980016/S939 · 2025-10-28

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, listed by FDA (PMA supplement, P980016/S939) with a decision date of 2025-10-28. Review panel: Cardiovascular.

FDA submission numberP980016/S939
PathwayPMA supplement
CompanyMedtronic Cardiac Rhythm Disease Management
Review panel (specialty)Cardiovascular
FDA decision date2025-10-28
Product codeLWS
ClassificationImplantable Cardioverter Defibrillator (Non-Crt)
Device class3
Review time (calendar days)29

Official FDA database record · FDA AI-enabled device list

All Cardiovascular AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.