|
Device | PULSE/PULSE DUO GENERATOR-MODEL 102/102R |
Generic Name | Stimulator, autonomic nerve, implanted (depression) |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S188 |
Date Received | 11/24/2015 |
Decision Date | 02/19/2016 |
Product Codes |
LYJ MUZ |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling changes being made to the Model 102/102R Technical Information Chapter of the VNS Therapy Physician’s Manual involving the addition/correction of information concerning generator performance exceptions. |