DEN210003 is an FDA 510(k) submission for the SureTune4 Software. This device is classified as a Brain Stimulation Programming Planning Software. (Class II - Special Controls, product code QQC).
Submitted by Medtronic Neuromodulation (Minneapolis, US). The FDA issued a Not Cleared (DENG) decision on August 23, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5855. The Brain Stimulation Programming Planning Software Is A Prescription Device Intended To Assist In Planning Stimulation Programming For Implanted Brain Stimulators..
| 510(k) Number | DEN210003 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 03, 2021 |
| Decision Date | August 23, 2021 |
| Days to Decision | 201 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QQC - Brain Stimulation Programming Planning Software. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5855 |
| Definition | The Brain Stimulation Programming Planning Software Is A Prescription Device Intended To Assist In Planning Stimulation Programming For Implanted Brain Stimulators. |