PMA P970003S251

Device: VNS Therapy Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S251
Product code: LYJ
Decision date: 2025-11-25
Classification: Neurology
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: approval for a new version of the M3100 v2.0 Clinician Programmer update, including a new Pause Therapy function, new version of the M2000 v1.1.3.0 Wand, and updates to the Digital Product Platform

Current openFDA PMA Record#

Device: VNS Therapy Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S251
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2025-11-25
Decision code: APPR
Date received: 2025-09-02
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a new version of the M3100 v2.0 Clinician Programmer update, including a new Pause Therapy function, new version of the M2000 v1.1.3.0 Wand, and updates to the Digital Product Platform