PMA P970003S150

Device
VNS THERAPY SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S150
Product code
MUZ
Decision date
2012-07-26
Classification
Stimulator, Autonomic Nerve, Implanted (depression)
Generic name
Stimulator, autonomic nerve, implanted (depression)
Approval order statement
UPDATES TO THE ELECTRICAL TEST SYSTEM SOFTWARE FOR VARIOUS MODELS OF THE VNS THERAPY SYSTEM PULSE GENERATORS.

Current openFDA PMA Record#

Device
VNS THERAPY SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S150
Product code
MUZ
Generic name
Stimulator, autonomic nerve, implanted (depression)
Decision date
2012-07-26
Decision code
OK30
Date received
2012-07-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
UPDATES TO THE ELECTRICAL TEST SYSTEM SOFTWARE FOR VARIOUS MODELS OF THE VNS THERAPY SYSTEM PULSE GENERATORS.