- Device
- Pulse, PulseDuo, DemiPulse, DemiPulseDuo, AspireHC, Aspire SR Generators.
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S197
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2016-07-28
- Decision code
- APPR
- Date received
- 2016-05-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the labeling to update stimulation dosing strategies and modify ECG filter settings.