PMA P970003S066

Device
VNS THERAPY SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S066
Product code
LYJ
Decision date
2006-06-08
Classification
Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name
Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement
APPROVAL FOR MODIFICATIONS TO THE MODEL 250 PROGRAMMING SOFTWARE VERSION 7.1.

Current openFDA PMA Record#

Device
VNS THERAPY SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S066
Product code
LYJ
Generic name
Stimulator, autonomic nerve, implanted for epilepsy
Decision date
2006-06-08
Decision code
APPR
Date received
2006-04-17
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MODIFICATIONS TO THE MODEL 250 PROGRAMMING SOFTWARE VERSION 7.1.