PMA P970003S096

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S096
Product code: LYJ
Decision date: 2008-02-22
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE DEMIPULSE AND PULSE DUO GENERATOR, MODELS 103 AND 104 WHICH PROVIDE INSTRUCTIONAL STEPS IN THE EVENT THAT THE USER ENCOUNTERS A MESSAGE THAT THE PULSE GENERATOR IS CURRENTLY DISABLED.

Current openFDA PMA Record#

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S096
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2008-02-22
Decision code: APPR
Date received: 2008-01-23
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE DEMIPULSE AND PULSE DUO GENERATOR, MODELS 103 AND 104 WHICH PROVIDE INSTRUCTIONAL STEPS IN THE EVENT THAT THE USER ENCOUNTERS A MESSAGE THAT THE PULSE GENERATOR IS CURRENTLY DISABLED.