PMA P970003S151

Device
VNS THERAPY SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S151
Product code
MUZ
Decision date
2012-09-06
Classification
Stimulator, Autonomic Nerve, Implanted (depression)
Generic name
Stimulator, autonomic nerve, implanted (depression)
Approval order statement
ADDITION OF A FIXTURE FOR CLEANING OF A COMPONENT.

Current openFDA PMA Record#

Device
VNS THERAPY SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S151
Product code
MUZ
Generic name
Stimulator, autonomic nerve, implanted (depression)
Decision date
2012-09-06
Decision code
OK30
Date received
2012-08-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A FIXTURE FOR CLEANING OF A COMPONENT.