Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD
FDA premarket approval P980016/S913 · decided 2025-06-05
Approval details
- PMA number
- P980016
- Supplement
- S913
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2024-12-20
- Decision date
- 2025-06-05
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for an update to the transition tooling used in Cobalt/Crome device battery manufacturing
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