Baseline Operating System Software (BOSS) for CareLink and Encore Programmers
FDA premarket approval P890003/S411 · decided 2019-07-23
Approval details
- PMA number
- P890003
- Supplement
- S411
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Baseline Operating System Software (BOSS) for CareLink and Encore Programmers
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2019-04-25
- Decision date
- 2019-07-23
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to the Medtronic CareLink 2090 Programmer Model 9986 and CareLink Encore 29901 Programmer Model SW028 Baseline Operating System Software.
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