VNS Therapy SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer
FDA premarket approval P970003/S218 · decided 2018-07-27
Approval details
- PMA number
- P970003
- Supplement
- S218
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VNS Therapy SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2018-04-30
- Decision date
- 2018-07-27
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- 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.
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