|
Trade Name | Activa Dystonia Therapy System, Percept PC BrainSense |
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 | S319 |
Date Received | 05/11/2022 |
Decision Date | 05/24/2022 |
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 Approval for medtronic’s external supplier, medicoil, to qualify additional new equipment for the coil winding and laser processes of minicoils components. |