|
Device | VNS THERAPY SYSTEM, MODEL 302 |
Generic Name | STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S058 |
Date Received | 07/20/2005 |
Decision Date | 09/29/2005 |
Product Code |
LYJ |
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 CHANGES TO THE MODEL 302 LEAD PHYSICIAN'S MANUAL CLARIFYING INFORMATION REGARDING HANDLING TO AVOID DAMAGE TO THE LEAD AND HELICAL ELECTRODES. |