PMA P970003S175

Device
VNS THERAPY DEMIPULSE AND VNS THERAPY DEMIPULSE DUO
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S175
Product code
MUZ
Decision date
2014-12-17
Classification
Stimulator, Autonomic Nerve, Implanted (depression)
Generic name
Stimulator, autonomic nerve, implanted (depression)
Approval order statement
IMPLEMENTATION OF A NEW ROUTING FIXTURE.

Current openFDA PMA Record#

Device
VNS THERAPY DEMIPULSE AND VNS THERAPY DEMIPULSE DUO
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S175
Product code
MUZ
Generic name
Stimulator, autonomic nerve, implanted (depression)
Decision date
2014-12-17
Decision code
OK30
Date received
2014-11-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENTATION OF A NEW ROUTING FIXTURE.