PMA P010015S458
- Device
- Consulta CRT-P, Syncra CRT-P, Viva CRT-P
- Applicant
- Medtronic, Inc.
- Product code
- LWP
- Decision date
- 2021-02-09
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for updates to the MyCareLink Patient Monitor firmware.
Current openFDA PMA Record#
- Device
- Consulta CRT-P, Syncra CRT-P, Viva CRT-P
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S458
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-02-09
- Decision code
- APPR
- Date received
- 2020-11-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to the MyCareLink Patient Monitor firmware.