SureTune4 Software

Brain Stimulation Programming Planning Software.

Medtronic Neuromodulation

The following data is part of a De Novo classification by Medtronic Neuromodulation with the FDA for Suretune4 Software.

Pre-market Notification Details

DeNovo IDDEN210003
Device Name:SureTune4 Software
ClassificationBrain Stimulation Programming Planning Software.
Applicant Medtronic Neuromodulation 7000 Central Ave., N.e. Minneapolis,  MN  55432
ContactTeal Bjoraker
Product CodeQQC  
CFR Regulation Number882.5855 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardNeurology
Classification AdvisoryNeurology
Date Received2021-02-03
Decision Date2021-08-23
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
00763000421212 DEN210003 000

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