Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD
FDA premarket approval P980016/S824 · decided 2022-07-20
Approval details
- PMA number
- P980016
- Supplement
- S824
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2022-06-16
- Decision date
- 2022-07-20
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for changes to the Cobalt/Crome devices associated with the Short Circuit Protection.
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