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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name brain stimulation programming planning software.
De Novo Number DEN210003
Device Name SureTune4 Software
Requester
Medtronic Neuromodulation
7000 central ave., n.e.
minneapolis,  MN  55432
Contact teal bjoraker
Regulation Number882.5855
Classification Product Code
QQC  
Date Received02/03/2021
Decision Date 08/23/2021
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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