- Device
- Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, and Solara Quadripolar dual
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S456
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- 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.