PMA P090013S179
- Device
- REVO MRI
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S179
- Product code
- LWP
- Decision date
- 2015-05-04
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR FIRMWARE UPDATES TO THE MEDTRONIC MODEL 25000 MYCARELINK SMART READER FOR USE WITH THE DEVICES.
Current openFDA PMA Record#
- Device
- REVO MRI
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S179
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2015-05-04
- Decision code
- APPR
- Date received
- 2015-03-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR FIRMWARE UPDATES TO THE MEDTRONIC MODEL 25000 MYCARELINK SMART READER FOR USE WITH THE DEVICES.