NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
FDA premarket approval P970003/S046 · decided 2003-09-30
Approval details
- PMA number
- P970003
- Supplement
- S046
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2002-11-29
- Decision date
- 2003-09-30
- Days to decision
- 305 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR AN ALTERNATIVE STERILIZATION PROCESS (HYDROGEN PEROXIDE GAS PLASMA USING THE STERRAD 200 GMP STERILIZER) FOR THE MODEL 401 TUNNELER AND APPROVAL OF A PROTOCOL FOR B1 INCUBATION REDUCTION AND SHELF LIFE STUDY, AS WELL AS A NEW STERILIZATION FACILITY (CYBERONICS, INC., HOUSTON, TEXAS).
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510(k) clearances by this applicant
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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 |