- Device
- CareLink SmartSync Platform Application (M01A01); CareLink SmartSync Common Application (M01A02); CareLink SmartSync Hos
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S485
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2026-05-06
- Decision code
- APPR
- Date received
- 2026-02-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for new CareLink SmartSync Adapta Versa Sensia application and supporting software and firmware platform updates