PMA P090013S206
- Device
- REVO MRI, SURESCAN IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S206
- Product code
- LWP
- Decision date
- 2015-12-08
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
Current openFDA PMA Record#
- Device
- REVO MRI, SURESCAN IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S206
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2015-12-08
- Decision code
- APPR
- Date received
- 2015-10-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.