PMA P970003S177

Device
VNS THERAPY SYSTEM PROGRAMMING SOFTWARE
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S177
Product code
MUZ
Decision date
2015-04-10
Classification
Stimulator, Autonomic Nerve, Implanted (depression)
Generic name
Stimulator, autonomic nerve, implanted (depression)
Approval order statement
ADDITIONAL INSPECTION STEP.

Current openFDA PMA Record#

Device
VNS THERAPY SYSTEM PROGRAMMING SOFTWARE
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S177
Product code
MUZ
Generic name
Stimulator, autonomic nerve, implanted (depression)
Decision date
2015-04-10
Decision code
OK30
Date received
2015-03-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITIONAL INSPECTION STEP.