|
Device | NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM |
Generic Name | STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S014 |
Date Received | 12/21/1998 |
Decision Date | 01/20/1999 |
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 labeling changes being made to the Model 100 NCP PUlse Generator Physician's Manual, the Model 300 NCP Bipolar Lead Physician's Manual, and the Patient's Manual for the NCP System. |