N¿VISION PROGRAMMING SYSTEM
FDA premarket approval P960009/S041 · decided 2008-11-05
Approval details
- PMA number
- P960009
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- N¿VISION PROGRAMMING SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2007-08-31
- Decision date
- 2008-11-05
- Days to decision
- 432 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR SOFTWARE UPDATES MADE TO NVISION PROGRAMMING SYSTEM MODEL 8840.
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510(k) clearances by this applicant
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|---|---|---|
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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