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

Device Identifier	submissionNumber	Supplement
00763000421212	DEN210003	000