PMA P090013S230
- Device
- Revo MRI, EnRhythm MRI
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S230
- Product code
- LWP
- Decision date
- 2016-09-06
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.
Current openFDA PMA Record#
- Device
- Revo MRI, EnRhythm MRI
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S230
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-09-06
- Decision code
- APPR
- Date received
- 2016-06-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.