|
Trade Name | SOLETRA/LEADS/EXTENSIONS/ACTIVA THERAPY DYSTONIA KIT |
Classification Name | implanted subcortical electrical stimulator (motor disorders) |
Generic Name | implanted subcortical electrical stimulator (motor disorders) |
Applicant |
MEDTRONIC NEUROMODULATION |
7000 central avenue ne |
rcw 225 |
minneapolis, MN 55432 |
|
HDE Number | H020007 |
Supplement Number | S051 |
Date Received | 07/18/2011 |
Decision Date | 12/16/2011 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of the model 37601 activa pc, and models 37602 and 37603 activa sc neurostimulators (with associated system components and related labeling changes) for medtronic dbs therapy system for dystonia. |