PMA P090013S198
- Device
- REVO MRI
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S198
- Product code
- LWP
- Decision date
- 2015-10-07
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE FIRMWARE UPDATES FOR THE HOME MONITOR SYSTEMS, WHICH WILL BE USED WITH THE IMPLANTABLE DEVICES.
Current openFDA PMA Record#
- Device
- REVO MRI
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S198
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2015-10-07
- Decision code
- APPR
- Date received
- 2015-08-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE FIRMWARE UPDATES FOR THE HOME MONITOR SYSTEMS, WHICH WILL BE USED WITH THE IMPLANTABLE DEVICES.