|
Trade Name | DEEP BRAIN STIMULATION FOR DYSTONIA |
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 | S031 |
Date Received | 01/07/2010 |
Decision Date | 03/24/2010 |
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 reformulation of the hotmelt adhesive used for medtronic neuromodulation sterile barrier blister packages. |