PMA P970003S152

Device
VNS THERAPY PULSE GENERATOR, 102/102R
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S152
Product code
MUZ
Decision date
2012-09-13
Classification
Stimulator, Autonomic Nerve, Implanted (depression)
Generic name
Stimulator, autonomic nerve, implanted (depression)
Approval order statement
USE OF ALTERNATE SCHOTTKY DIODES FOR THE VNS THERAPY IMPLANTABLE PULSE GENERATORS AND THE PROGRAMMING WAND.

Current openFDA PMA Record#

Device
VNS THERAPY PULSE GENERATOR, 102/102R
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S152
Product code
MUZ
Generic name
Stimulator, autonomic nerve, implanted (depression)
Decision date
2012-09-13
Decision code
OK30
Date received
2012-08-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE OF ALTERNATE SCHOTTKY DIODES FOR THE VNS THERAPY IMPLANTABLE PULSE GENERATORS AND THE PROGRAMMING WAND.