NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
FDA premarket approval P970003/S015 · decided 1999-01-28
Approval details
- PMA number
- P970003
- Supplement
- S015
- 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
- 1998-12-28
- Decision date
- 1999-01-28
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for a new manufacturing site located at Cyberonics, Inc., 16511 Space Center Blvd., Suite 500, Houston, TX.
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| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
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