PMA P970003S239

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S239
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 the warning and precaution sections in the VNS Therapy Physicians Manuals for both Epilepsy and Depression regarding a clearer message directing the reader to view and reference the LivaNova magnetic resonance imaging (MRI) guidelines for any considerations for MRI scans in patients with the VNS Therapy System.

Current openFDA PMA Record#

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S239
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 the warning and precaution sections in the VNS Therapy Physicians Manuals for both Epilepsy and Depression regarding a clearer message directing the reader to view and reference the LivaNova magnetic resonance imaging (MRI) guidelines for any considerations for MRI scans in patients with the VNS Therapy System.