REVO MRI SURESCAN IPG
FDA premarket approval P090013/S235 · decided 2016-11-17
Approval details
- PMA number
- P090013
- Supplement
- S235
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REVO MRI SURESCAN IPG
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2016-09-08
- Decision date
- 2016-11-17
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for software modification to the MyCareLink Patient Monitor Model 24950.
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