|
Device | VNS THERAPY SYSTEM/NCP/VNS PULSE GENERATORS |
Generic Name | STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S109 |
Date Received | 04/19/2010 |
Decision Date | 05/18/2010 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A LABELING MODIFICATION REGARDING THE INTERNAL CLOCK RESET IN THE MODEL 100, 101, 102 AND 102R IMPLANTED PULSE GENERATORS (IPGS). |