PMA P010015S464
- Device
- CareLink SmartSync Percepta Serena Solara Application
- Applicant
- Medtronic, Inc.
- Product code
- LWP
- Decision date
- 2021-02-12
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for software application release SmartSync Application Update Version 3.2.4..
Current openFDA PMA Record#
- Device
- CareLink SmartSync Percepta Serena Solara Application
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S464
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-02-12
- Decision code
- APPR
- Date received
- 2020-12-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software application release SmartSync Application Update Version 3.2.4..