PMA P980016S433
- Device
- ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, INSYNC MARQUIS, PROTECTA XT, DR, PROTEXTA DR, PROTEXTA XT, VR,
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S433
- Product code
- LWS
- Decision date
- 2013-10-15
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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
- ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, INSYNC MARQUIS, PROTECTA XT, DR, PROTEXTA DR, PROTEXTA XT, VR,
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S433
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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.