Revo MRI, EnRhythm MRI
FDA premarket approval P090013/S230 · decided 2016-09-06
Approval details
- PMA number
- P090013
- Supplement
- S230
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Revo MRI, EnRhythm MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2016-06-24
- Decision date
- 2016-09-06
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- 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.
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