PMA P970003S215
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S215
- Product code
- LYJ
- Decision date
- 2018-02-14
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Approval for updates to the Model 3000 Programming Software (from v1.0 to v1.0.2 and then to v1.0.2.4) based on a field events which revealed that the M3000 v1.0 Software does not interrogate or program certain generator memory locations when used with Model 103, Model 104, Model 105 and Model 106 Generators.
Current openFDA PMA Record#
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S215
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2018-02-14
- Decision code
- APPR
- Date received
- 2017-12-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to the Model 3000 Programming Software (from v1.0 to v1.0.2 and then to v1.0.2.4) based on a field events which revealed that the M3000 v1.0 Software does not interrogate or program certain generator memory locations when used with Model 103, Model 104, Model 105 and Model 106 Generators.