|
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 | S192 |
Date Received | 07/27/2017 |
Decision Date | 08/24/2017 |
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 A transfer of receiving and incoming inspection activities for device components (i. E. , screw-conn set, crimp block 7495, and block- connector, set screw) used in the manufacture of medtronic neuromodulation therapy delivery products, from the medtronic rice creek facility to the medtronic puerto rico operations company (mproc)-villalba, mproc-juncos, and the fedex/3pl (third party logistics) facility in guaynabo, puerto rico. |