PMA P890003S434
- Device
- MyCareLink Patient Monitor
- Applicant
- Medtronic, Inc.
- Product code
- NVZ
- Decision date
- 2020-11-02
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Approval for an alternate cellular modem and firmware update to M13.0.
Current openFDA PMA Record#
- Device
- MyCareLink Patient Monitor
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S434
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2020-11-02
- Decision code
- APPR
- Date received
- 2020-08-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternate cellular modem and firmware update to M13.0.