PMA P890003S284
- Device
- REVEAL DX, REVEAL XT
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S284
- Product code
- OSR
- Decision date
- 2013-10-15
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- APPROVAL FOR A FIRMWARE UPDATE TO VERSION CM2490C_10V5 FOR THE MODEL 2490C CARELINK REMOTE HOME MONITOR AND FOR A FIRMWARE UPDATE TO VERSION CM2490G_14V2 FOR THE 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A CARDIOSIGHT READER, AND 2020B CARELINK EXPRESS MONITOR FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- REVEAL DX, REVEAL XT
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S284
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2013-10-15
- Decision code
- APPR
- Date received
- 2013-08-12
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR A FIRMWARE UPDATE TO VERSION CM2490C_10V5 FOR THE MODEL 2490C CARELINK REMOTE HOME MONITOR AND FOR A FIRMWARE UPDATE TO VERSION CM2490G_14V2 FOR THE 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A CARDIOSIGHT READER, AND 2020B CARELINK EXPRESS MONITOR FOR THE DEVICES.