PMA P890003S283
- Device
- MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S283
- Product code
- OSR
- Decision date
- 2013-10-07
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- APPROVAL FOR A FIRMWARE UPDATE TO THE MODEL 2490C CARELINK REMOTE HOME MONITOR FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S283
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2013-10-07
- Decision code
- APPR
- Date received
- 2013-08-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A FIRMWARE UPDATE TO THE MODEL 2490C CARELINK REMOTE HOME MONITOR FOR THE DEVICES.