NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
FDA premarket approval P970003/S037 · decided 2002-02-22
Approval details
- PMA number
- P970003
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2002-01-10
- Decision date
- 2002-02-22
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN AND MATERIAL OF THE SEPTUM USED ON THE MODEL 101 NCP PULSE GENERATOR.
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