NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
FDA premarket approval P970003/S055 · decided 2005-02-01
Approval details
- PMA number
- P970003
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2004-11-08
- Decision date
- 2005-02-01
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE - VERSION 7.0 FOR USE WITH MODEL 100 VERSIONS B AND C, MODEL 101 VERSIONS 1 AND 2, AND MODELS 102 AND 102R PULSE GENERATORS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |