CareLink Programmer and Encore Programmer Software
FDA premarket approval P890003/S384 · decided 2018-02-23
Approval details
- PMA number
- P890003
- Supplement
- S384
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CareLink Programmer and Encore Programmer Software
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2017-12-14
- Decision date
- 2018-02-23
- Days to decision
- 71 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 Software Model 9986 and Encore Model SW028 Programmer Baseline Operating System Software.
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510(k) clearances by this applicant
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|---|---|---|
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| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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