|
Device | VNS THERAPY PULSE/PULSE DUO GENERATOR |
Generic Name | Stimulator, autonomic nerve, implanted (depression) |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S155 |
Date Received | 11/19/2012 |
Decision Date | 02/25/2013 |
Product Codes |
LYJ MUZ |
Advisory Committee |
Neurology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE ELECTRICAL TEST SYSTEM (ETS) SOFTWARE USED IN PRODUCTION. |