- Device
- CareLink SmartSync Platform and Common Application
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S428
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2020-05-17
- Decision code
- APPR
- Date received
- 2020-02-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for CareLink SmartSync Common Application version 3.2.01, CareLink SmartSync Azure Astra Application version 3.2.02, CareLink SmartSync Percepta Serena Solara Application version 3.2.02.