PMA P970003S231

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
Product code: LYJ
Decision date: 2020-05-13
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: Approval for a new generator known as SenTiva Duo Model 1000-D Generator. The Model 1000-D Generator is identical to the Model 1000 SenTiva Generator with the exception of the header which will be compatible with dual pin leads.

Current openFDA PMA Record#

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S231
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2020-05-13
Decision code: APPR
Date received: 2020-02-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a new generator known as SenTiva Duo Model 1000-D Generator. The Model 1000-D Generator is identical to the Model 1000 SenTiva Generator with the exception of the header which will be compatible with dual pin leads.