|
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 | S158 |
Date Received | 05/31/2016 |
Decision Date | 06/29/2016 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implement a rework process for filling bubbles within the medical adhesive on the implantable pulse generator (ipg) connector blocks. |