NEUROCYBERNETIC PROSTHESES(NCP) SYSTEM
FDA premarket approval P970003/S039 · decided 2002-06-18
Approval details
- PMA number
- P970003
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEUROCYBERNETIC PROSTHESES(NCP) SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2002-04-17
- Decision date
- 2002-06-18
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 402 TUNNELING TOOL (VERSION 1), RESULTING IN THE NEW VNS THERAPY TUNNELER, MODEL 402 (VERSION 2), AND MODIFICATIONS TO THE EXISTING MODEL 500 ACCESSORY PACK, RESULTING IN THE NEW VNS THERAPY ACCESSORY PACK, MODEL 502.
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|---|---|---|
| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
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