PMA P970003S241

Device: VNS Therapy System; Model 3100 Programming Software; Model 2000 Programming Wand
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S241
Product code: LYJ
Decision date: 2023-09-15
Classification: Neurology
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: Approval for the new Model 3100 v1.0 Programmer Software, updated M2000 v1.1.2.2 Programming Wand Firmware, and the new Digital Products Platform.

Current openFDA PMA Record#

Device: VNS Therapy System; Model 3100 Programming Software; Model 2000 Programming Wand
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S241
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2023-09-15
Decision code: APPR
Date received: 2023-04-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the new Model 3100 v1.0 Programmer Software, updated M2000 v1.1.2.2 Programming Wand Firmware, and the new Digital Products Platform.