|
Trade Name | ACTIVA DYSTONIA THERAPY SYSTEM |
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 | S151 |
Date Received | 12/14/2015 |
Decision Date | 02/29/2016 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of new/updated safety information, specifically a warning for status dystonicus (for dystonia labeling) and potential adverse events, and the consolidation of therapy-wide adverse events supplemented by indication-specific labeling addenda. |