PMA P970003S249

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S249
Product code: LYJ
Decision date: 2026-08-12
Classification: Neurology
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: approval for 1) changing the term “partial onset seizures” to “focal onset seizures” in the Indications for Use, 2) changing the term “sudden unexplained death” to “sudden unexpected death”, 3) removing the “Warning” label associated with SUDEP-related information and moving the SUDEP-related information from the Warnings section to the Clinical Studies section of the Physician’s Manual, 4) aligning the SUDEP-related information in the Patient Guide with the Physician’s Manual and removing the “Caution” label associated with SUDEP-related information.

Current openFDA PMA Record#

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S249
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2026-08-12
Decision code: APPR
Date received: 2025-08-11
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for 1) changing the term “partial onset seizures” to “focal onset seizures” in the Indications for Use, 2) changing the term “sudden unexplained death” to “sudden unexpected death”, 3) removing the “Warning” label associated with SUDEP-related information and moving the SUDEP-related information from the Warnings section to the Clinical Studies section of the Physician’s Manual, 4) aligning the SUDEP-related information in the Patient Guide with the Physician’s Manual and removing the “Caution” label associated with SUDEP-related information.