Enhancements to Software Model 9986 version 2.11.1 and Model SW028 to version 8.2.1
FDA premarket approval P890003/S401 · decided 2019-01-07
Approval details
- PMA number
- P890003
- Supplement
- S401
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Enhancements to Software Model 9986 version 2.11.1 and Model SW028 to version 8.2.1
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2018-11-16
- Decision date
- 2019-01-07
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to the Baseline Operating System Software in the Medtronic CareLink 2090 Programmer Model 9986 software and CareLink Encore Programmer Model SW028 software.
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