Devices · Medtronic Cardiac Rhythm Disease Management

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

Medtronic Cardiac Rhythm Disease Management is listed for Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (P980016/S939). The FDA list gives October 28, 2025 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the PMA pathway. openFDA describes product code LWS as “Implantable Cardioverter Defibrillator (Non-Crt)”: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980016S939

Official FDA database record

Date of final decision

October 28, 2025

Company on the FDA list

Medtronic Cardiac Rhythm Disease Management

Lead panel

Cardiovascular

Primary product code

LWS

openFDA device name for the code

Implantable Cardioverter Defibrillator (Non-Crt)

Device class

3

Regulation number

Not returned

openFDA decision description

Not returned

openFDA decision code

Not returned

Statement or summary label

Not returned