|
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 | S131 |
Date Received | 02/27/2015 |
Decision Date | 05/12/2015 |
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 material changes to two non-implantable screening cables (the alligator clip screening cable accessory kit and the twist lock screening cable accessory kit) to comply with the european union restriction of hazardous substances ii directive 2011/65/eu. |