|
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 | S258 |
Date Received | 11/15/2019 |
Decision Date | 12/11/2019 |
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 Update medtronics manufacturing software, manufacturing execution system to factory works (release 9. 7), which is comprised of (1) fw business rule client 9. 7, (2) fw configuration client 9. 2. 2, and (3) integrated manufacturing process management (impm) web services (ws) 3. 6. |