|
Trade Name | Activa Dystonia Therapy System, Percept PC BrianSense |
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 | S316 |
Date Received | 03/18/2022 |
Decision Date | 06/15/2022 |
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 Changes to the medtronic model a610 dbs clinician programmer application version 3. 0. The changes consist of a fix to a software defect subject to field corrective action fa1188 reported to fda on september 23, 2021, as well as fixes to other minor defects in the a610 application. |