PMA P970003S062
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S062
- Product code
- LYJ
- Decision date
- 2005-12-28
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE - VERSION 7.2 FOR USE WITH MODEL 100 VERSIONS B AND C, MODEL 101 VERSIONS 1 AND 2, AND MODELS 102 AND 102R PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S062
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2005-12-28
- Decision code
- APPR
- Date received
- 2005-11-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE - VERSION 7.2 FOR USE WITH MODEL 100 VERSIONS B AND C, MODEL 101 VERSIONS 1 AND 2, AND MODELS 102 AND 102R PULSE GENERATORS.