SenTiva Model 1000 Generator
FDA premarket approval P970003/S221 · decided 2019-03-27
Approval details
- PMA number
- P970003
- Supplement
- S221
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SenTiva Model 1000 Generator
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2018-12-27
- Decision date
- 2019-03-27
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for firmware updates of the Model 1000 Generator.
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