PMA P970003S218
- Device
- VNS Therapy SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S218
- Product code
- LYJ
- Decision date
- 2018-07-27
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Approval for updates to the Model1000 SenTiva Generator, Model2000 Programming Wand, and Model3000 Programmer; the updates are referred to as Version 1.5. These changes spanned new outer packaging for leads, generators, and accessory packs, Model1000 Generator firmware corrections, Model1000 Heart Rate Sensing requirement updates, Model2000 Wand Firmware Corrections, Model2000 Wand Label Cover Addition, and Model3000 Programmer Software Enhancements and Corrections.
Current openFDA PMA Record#
- Device
- VNS Therapy SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S218
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2018-07-27
- Decision code
- APPR
- Date received
- 2018-04-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to the Model1000 SenTiva Generator, Model2000 Programming Wand, and Model3000 Programmer; the updates are referred to as Version 1.5. These changes spanned new outer packaging for leads, generators, and accessory packs, Model1000 Generator firmware corrections, Model1000 Heart Rate Sensing requirement updates, Model2000 Wand Firmware Corrections, Model2000 Wand Label Cover Addition, and Model3000 Programmer Software Enhancements and Corrections.