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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 NameMedtronic Dystonia Therapy System
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 NumberS290
Date Received02/23/2021
Decision Date05/07/2021
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 
Approval for software changes to the medtronic model a620 patient programmer application (ppa) which consist of 1) fixing a defect that prevents the software from communicating with certain model b35200 inss that have tel-m ids containing particular values, 2) updating the impedance test that is used to support the mri eligibility feature of the a620 ppa, and 3) other minor changes and bug fixes.
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