Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD
FDA premarket approval P980016/S904 · decided 2025-01-14
Approval details
- PMA number
- P980016
- Supplement
- S904
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2024-10-16
- Decision date
- 2025-01-14
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- change of sub-tier suppliers, design update to Tel-B antenna assembly, and automation of manufacturing process
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