|
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 | S074 |
Date Received | 10/10/2006 |
Decision Date | 10/31/2006 |
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 THE ADDITION OF A PRECAUTION TO THE MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.6.1 AND MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.7.0 IN THREE DIFFERENT PLACES IN EACH OF THE RESPECTIVE MANUALS. |