CYBERONICS VNS THERAPY
FDA premarket approval P970003/S065 · decided 2011-10-17
Approval details
- PMA number
- P970003
- Supplement
- S065
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CYBERONICS VNS THERAPY
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2006-03-01
- Decision date
- 2011-10-17
- Days to decision
- 2056 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR LABELING CHANGES RELATED TO THE USE OF MRI SYSTEMS WITH THE DEVICE.
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510(k) clearances by this applicant
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|---|---|---|
| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
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