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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 | S234 |
Date Received | 12/18/2018 |
Decision Date | 03/01/2019 |
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 Add a polyethylene terephthalate (pet) slip tube over proximal end of each cable conductor to prevent mechanical locking of the build epoxy to the ethylene tetrafluoroethylene (etfe) coated wire cables for dbs extension models 37085 and 37086. |