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, Percept™ PC BrainSense™ |
Applicant |
MEDTRONIC NEUROMODULATION |
7000 central avenue ne |
rcw 225 |
minneapolis, MN 55432 |
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HDE Number | H020007 |
Supplement Number | S335 |
Date Received | 11/23/2022 |
Decision Date | 12/08/2022 |
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 Implementation of a validated test method for the incoming inspection of a component used at the medtronic energy and component center (mecc). |
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