- Device
- Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S824
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-07-20
- Decision code
- APPR
- Date received
- 2022-06-16
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the Cobalt/Crome devices associated with the Short Circuit Protection.