PMA P970003S229

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S229
Product code: LYJ
Decision date: 2020-01-13
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: Approval for the changes that are being made to the firmware of the Model 1000 Generator (SN >= 100,000) to prevent resetting the microcontroller unit when an uncorrectable FRAM bit error is detected.

Current openFDA PMA Record#

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S229
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2020-01-13
Decision code: APPR
Date received: 2019-10-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the changes that are being made to the firmware of the Model 1000 Generator (SN >= 100,000) to prevent resetting the microcontroller unit when an uncorrectable FRAM bit error is detected.