PMA P970003S190

Device
VNS THERAPY SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S190
Product code
MUZ
Decision date
2016-04-29
Classification
Stimulator, Autonomic Nerve, Implanted (depression)
Generic name
Stimulator, autonomic nerve, implanted (depression)
Approval order statement
Approval for a new serial adapter cable to connect the programming computer to the programming wand.

Current openFDA PMA Record#

Device
VNS THERAPY SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S190
Product code
MUZ
Generic name
Stimulator, autonomic nerve, implanted (depression)
Decision date
2016-04-29
Decision code
APPR
Date received
2016-02-04
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a new serial adapter cable to connect the programming computer to the programming wand.