PMA P970003S040

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S040
Product code: LYJ
Decision date: 2002-06-20
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 101 (VERSION 2) IN-LINE NCP PULSE GENERATOR AND MODEL 302 (VERSION 1) IN-LINE NCP BIPOLAR LEAD, RESULTING IN THE NEW VNS THERAPY PULSE, MODEL 102 GENERATOR AND THE VNS THERAPY LEAD, MODEL 302 (VERSION 1.1). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VNS THERAPY SYSTEM.

Current openFDA PMA Record#

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S040
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2002-06-20
Decision code: APPR
Date received: 2002-04-19
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 101 (VERSION 2) IN-LINE NCP PULSE GENERATOR AND MODEL 302 (VERSION 1) IN-LINE NCP BIPOLAR LEAD, RESULTING IN THE NEW VNS THERAPY PULSE, MODEL 102 GENERATOR AND THE VNS THERAPY LEAD, MODEL 302 (VERSION 1.1). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VNS THERAPY SYSTEM.