- Device
- CareLink SmartSync Platform, CareLink SmartSync Host Application, CareLink SmartSync Common Application, CareLink SmartS
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S444
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2021-05-27
- Decision code
- APPR
- Date received
- 2021-03-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for new cardiovascular implantable electronic device (CIED) software applications on the CareLink SmartSync Device Manager.