PMA P890003S443
- Device
- MyCareLink Patient Monitor
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S443
- Product code
- NVZ
- Decision date
- 2021-05-05
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Approval for firmware updates (Version M7.6) to the MyCareLink Patient Monitor Model 24950 to enable support for an alternate modem.
Current openFDA PMA Record#
- Device
- MyCareLink Patient Monitor
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S443
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2021-05-05
- Decision code
- APPR
- Date received
- 2021-02-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for firmware updates (Version M7.6) to the MyCareLink Patient Monitor Model 24950 to enable support for an alternate modem.