PMA P970003S240

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S240
Product code: LYJ
Decision date: 2023-03-02
Classification: Neurology
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: Approval for updates to a warning header in the VNS Therapy Physicians Manuals for both Epilepsy and Depression to clarify section about VNS Therapy uses in which safety and effectiveness have not been established.

Current openFDA PMA Record#

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S240
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2023-03-02
Decision code: APPR
Date received: 2023-02-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updates to a warning header in the VNS Therapy Physicians Manuals for both Epilepsy and Depression to clarify section about VNS Therapy uses in which safety and effectiveness have not been established.