PMA P970003S247

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S247
Product code: LYJ
Decision date: 2025-05-02
Classification: Neurology
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: approval for replacement of the reed switch with giant magnetoresistor sensor for utilizing magnet mode within the implantable pulse generator (Model M1000 and M1000-D) as a corrective action for recall Z-1072-2025

Current openFDA PMA Record#

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S247
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2025-05-02
Decision code: APPR
Date received: 2025-03-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for replacement of the reed switch with giant magnetoresistor sensor for utilizing magnet mode within the implantable pulse generator (Model M1000 and M1000-D) as a corrective action for recall Z-1072-2025