- Device
- Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S768
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-04-16
- Decision code
- APPR
- Date received
- 2021-01-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of through-holes to transformer printed circuit board headers used in CRT-D and ICD devices.