VNS Therapy System
FDA premarket approval P970003/S215 · decided 2018-02-14
Approval details
- PMA number
- P970003
- Supplement
- S215
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VNS Therapy System
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2017-12-04
- Decision date
- 2018-02-14
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- 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.
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