- Device
- Astra S DR MRI, Astra S SR MRI, Astra XT DR MRI, Astra XT SR MRI, Azure S DR MRI, Azure S SR MRI, Azure XT DR MRI, Azure
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S659
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2021-01-28
- Decision code
- APPR
- Date received
- 2020-11-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for software updates necessary for release of software application releases SW030 (Orion) v8.2 and SW040 (CRT-P Quad) v8.4.