PMA P970003S092

Device
VNS THERAPY SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S092
Product code
LYJ
Decision date
2007-11-14
Classification
Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name
Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement
ADDITION OF AN AUTOMATED ELECTRICAL TEST STATION.

Current openFDA PMA Record#

Device
VNS THERAPY SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S092
Product code
LYJ
Generic name
Stimulator, autonomic nerve, implanted for epilepsy
Decision date
2007-11-14
Decision code
OK30
Date received
2007-10-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF AN AUTOMATED ELECTRICAL TEST STATION.