NEURO CYBERNETIC PROSTHESIS (NCP) SYSTEM
FDA premarket approval P970003/S012 · decided 1998-12-18
Approval details
- PMA number
- P970003
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEURO CYBERNETIC PROSTHESIS (NCP) SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 1998-11-17
- Decision date
- 1998-12-18
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for the Model 250 NCP Programming Software Version 4.3 (for use with Model 100 NCP Pulse Generator Versions B and C).
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