PMA P970003S041
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S041
- Product code
- LYJ
- Decision date
- 2002-06-18
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 250 PROGRAMMING SOFTWARE VERSION 6.1 (BUILD 4), RESULTING IN THE NEW VERSION 6.1 (BUILD 5).
Current openFDA PMA Record#
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S041
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2002-06-18
- Decision code
- APPR
- Date received
- 2002-04-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 250 PROGRAMMING SOFTWARE VERSION 6.1 (BUILD 4), RESULTING IN THE NEW VERSION 6.1 (BUILD 5).