|
Device | VNS Therapy System |
Generic Name | STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S239 |
Date Received | 02/01/2023 |
Decision Date | 03/02/2023 |
Product Codes |
LYJ MUZ |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to the warning and precaution sections in the VNS Therapy Physicians Manuals for both Epilepsy and Depression regarding a clearer message directing the reader to view and reference the LivaNova magnetic resonance imaging (MRI) guidelines for any considerations for MRI scans in patients with the VNS Therapy System. |