PMA P970003S244

Device: SenTiva Model 1000 and SenTiva Duo Model 1000-D 2024 Generator Firmware Maintenance
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S244
Product code: LYJ
Decision date: 2024-07-18
Classification: Neurology
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: Approval for adding Automatic Recovery function, for addressing open anomalies, and for minor enhancements to the crash logging and variable handling within the firmware for the Sentiva Model 1000 and Model 1000-D Generators (SN >= 400,000).

Current openFDA PMA Record#

Device: SenTiva Model 1000 and SenTiva Duo Model 1000-D 2024 Generator Firmware Maintenance
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S244
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2024-07-18
Decision code: APPR
Date received: 2024-04-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for adding Automatic Recovery function, for addressing open anomalies, and for minor enhancements to the crash logging and variable handling within the firmware for the Sentiva Model 1000 and Model 1000-D Generators (SN >= 400,000).