VNS THERAPY SYSTEM
FDA premarket approval P970003/S196 · decided 2016-07-13
Approval details
- PMA number
- P970003
- Supplement
- S196
- 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
- 2016-04-18
- Decision date
- 2016-07-13
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for the following device changes: 1) The Model 106 GeneratorÂ’s technical requirement for Heartbeat amplitude detection is being updated to include a minimum lower threshold (i.e. Minimum alower) for each of the generators five (5) gain settings (as well as adjustments to the maximum lower threshold (i.e. alower); 2) The Universal Test System is being updated of the Model 106 Generator so that the updated firmware can be loaded onto Model 106 generators; and 3) Universal Test System (UTS
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