PMA P970003S202

Device: VNS THERAPY ASPRICE HC AND ASPIRESR, DEMIPULSE AND DEMIPULSE DUO, PULSE AND PULSE DUO GENERATORS; VNS THERAPY PERENNIAD
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S202
Product code: LYJ
Decision date: 2016-08-12
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: Approval for labeling changes to address adverse events (AE) associated with the VNS stimulation following electrical cardioversion procedures.

Current openFDA PMA Record#

Device: VNS THERAPY ASPRICE HC AND ASPIRESR, DEMIPULSE AND DEMIPULSE DUO, PULSE AND PULSE DUO GENERATORS; VNS THERAPY PERENNIAD
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S202
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2016-08-12
Decision code: APPR
Date received: 2016-07-13
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling changes to address adverse events (AE) associated with the VNS stimulation following electrical cardioversion procedures.