- Device
- Visia AF MRI DF1 ICD, Visia AF MRI VR ICD, and Visia AF VR ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S731
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-05-08
- Decision code
- APPR
- Date received
- 2020-02-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for RAMware updates to ICD, CRT-D, CRT-P, and IPG devices and corresponding updates to Medtronic CareLink Programmer Model 2090 and Encore Programmer Model 29901 device applications SW034, SW035, SW030, and SW040.