PMA P970003S246

Device: VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S246
Product code: LYJ
Decision date: 2025-03-27
Classification: Neurology
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: approval to reduce the size of the universal product packaging (i.e. sales package product box) used in all of the VNS Therapy IPGs, Leads and Accessory Pack

Current openFDA PMA Record#

Device: VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S246
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2025-03-27
Decision code: APPR
Date received: 2024-12-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval to reduce the size of the universal product packaging (i.e. sales package product box) used in all of the VNS Therapy IPGs, Leads and Accessory Pack