PMA P980016S327
- Device
- ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II SECURA/VIRTUOSO II/INSYNC MARQUIS/VIRTUOSO/PROTECTA
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S327
- Product code
- LWS
- Decision date
- 2011-12-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A MEDTRONIC CARDIOSIGHT READER AND MODEL 2020B CARELINK EXPRESS MONITOR.
Current openFDA PMA Record#
- Device
- ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II SECURA/VIRTUOSO II/INSYNC MARQUIS/VIRTUOSO/PROTECTA
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S327
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2011-12-06
- Decision code
- APPR
- Date received
- 2011-11-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A MEDTRONIC CARDIOSIGHT READER AND MODEL 2020B CARELINK EXPRESS MONITOR.