NEUROCYBERNETIC PROTHESIS SYSTEM
FDA premarket approval P970003/S002 · decided 1997-10-09
Approval details
- PMA number
- P970003
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEUROCYBERNETIC PROTHESIS SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 1997-09-04
- Decision date
- 1997-10-09
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for the modified NCP(R) System Lead Connector Boot Design and the NCP(R) System Programming Software Version 4.1.
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