PMA P970003S037
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S037
- Product code
- LYJ
- Decision date
- 2002-02-22
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN AND MATERIAL OF THE SEPTUM USED ON THE MODEL 101 NCP PULSE GENERATOR.
Current openFDA PMA Record#
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S037
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2002-02-22
- Decision code
- APPR
- Date received
- 2002-01-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN AND MATERIAL OF THE SEPTUM USED ON THE MODEL 101 NCP PULSE GENERATOR.