Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device. |
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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 |
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HDE Number | H020007 |
Supplement Number | S228 |
Date Received | 10/30/2018 |
Decision Date | 11/08/2018 |
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 Consolidate the laser weld pull strength monitoring tests for four model families into one group (affected models: 977a160, 977a175, 977a190, 977a260, 977a275, 977a290, 977d160, 977d260, 3776, 3777, 3778, 37081, 37082, 37083, 37085, 37086). |
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