PMA P970003S003
- Device
- NEUROCYBERNETIC PROTHESIS SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S003
- Product code
- LYJ
- Decision date
- 1997-11-21
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Approval for the Model 250 NCP Software Version 5.0 modification.
Current openFDA PMA Record#
- Device
- NEUROCYBERNETIC PROTHESIS SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S003
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 1997-11-21
- Decision code
- APPR
- Date received
- 1997-09-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Model 250 NCP Software Version 5.0 modification.