NEUROCYBERNETIC PROTHESIS SYSTEM
FDA premarket approval P970003/S004 · decided 1998-01-29
Approval details
- PMA number
- P970003
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEUROCYBERNETIC PROTHESIS SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 1997-09-18
- Decision date
- 1998-01-29
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for NCP(R) Model 100C Pulse Generator with modifications to the microcontroller and battery. The device, as modified, will be marketed under the trade name NCP(R) Model 100C Pulse Generator ans is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with pertial onset seizures, which are refractory to anti-epileptic medications.
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|---|---|---|
| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
| RAP Femoral Venous Cannulae (K250283) | LivaNova USA, Inc. | 2025-07-10 |
| SMARxT Tubing and Connectors (K233702) | LivaNova USA, Inc. | 2024-08-08 |