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 ID | DEN210003 |
| Device Name: | SureTune4 Software |
| Classification | Brain Stimulation Programming Planning Software. |
| Applicant | Medtronic Neuromodulation 7000 Central Ave., N.e. Minneapolis, MN 55432 |
| Contact | Teal Bjoraker |
| Product Code | QQC |
| CFR Regulation Number | 882.5855 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device 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 Board | Neurology |
| Classification Advisory | Neurology |
| Type | Direct |
| Date Received | 2021-02-03 |
| Decision Date | 2021-08-23 |
| Reclassification Order: | Reclassification Order |
NIH GUDID Devices
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.