|
Device | PULSE/PULSE DUO GENERATOR; DEMIPULSE/DEMIPULSE DUO GENERATOR; ASPIREHC GENERATOR; ASPIRESR GENERATOR |
Generic Name | Stimulator, autonomic nerve, implanted (depression) |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S185 |
Date Received | 08/31/2015 |
Decision Date | 09/30/2015 |
Product Codes |
LYJ MUZ |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement IMPLEMENTATION OF AN ALTERNATE SPOT WELDING SYSTEM USED DURING MANUFACTURE OF THE VNS THERAPY SYSTEM. |