Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D
FDA premarket approval P980016/S926 · decided 2025-07-09
Approval details
- PMA number
- P980016
- Supplement
- S926
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2025-05-20
- Decision date
- 2025-07-09
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for minor design changes to the final filtered feedthrough assemblies for Implantable Cardioverter Defibrillators (ICDs) and Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-Ds)
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