|
Device | VNS THERAPY SYSTEM |
Generic Name | stimulator, autonomic nerve, implanted (depression) |
Applicant |
LivaNova USA, Inc. |
100 cyberonics blvd. |
houston, TX 77058 |
|
PMA Number | P970003 |
Supplement Number | S050 |
Date Received | 10/27/2003 |
Decision Date | 07/15/2005 |
Product Code |
MUZ
|
Docket Number | 05M-0283 |
Notice Date | 07/18/2005 |
Advisory Committee |
Neurology |
Supplement Type | panel track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | Yes |
Combination Product |
No
|
Approval Order Statement
APPROVAL FOR THE VNS THERAPY SYSTEM. THE DEVICE IS INDICATED FOR THE ADJUNCTIVE LONG-TERM TREATMENT OF CHRONIC OR RECURRENT DEPRESSION FOR PATIENTS 18 YEARS OF AGE OR OLDER WHO ARE EXPERIENCING A MAJOR DEPRESSIVE EPISODE AND HAVE NOT HAD AN ADEQUATE RESPONSE TO FOUR OR MORE ADEQUATE ANTIDEPRESSANT TREATMENTS. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
Labeling Part 2
|