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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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.
 
Trade Name(MRU) Percept and Activa Dystonia Therapy Systems
Classification Nameimplanted subcortical electrical stimulator (motor disorders)
Generic Nameimplanted subcortical electrical stimulator (motor disorders)
Applicant
Medtronic Neuromodulation
7000 central ave., ne, rcw225
minneapolis, MN 55432
HDE NumberH020007
Supplement NumberS257
Date Received10/18/2019
Decision Date06/24/2020
Product Code
MRU[ Registered Establishments with MRU ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Which requested approval for the following:• model b35200 percept pc implantable neurostimulator (ins);• model b31060 connector plug;• updates to the model a610 clinician programmer application (ppa) software to version 2. 0;• updates to the model a620 patient programmer application (cpa) to version 2. 0;• updates to the model 8880t2 communicator (clinician telemetry device) firmware; • new model th91 handset and communicator kit; and• labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new percept pc system.
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