510(k) DEN210003
DEN210003 is an FDA 510(k) premarket notification submitted by Medtronic Neuromodulation for the device "SureTune4 Software". The FDA issued a decision of De Novo granted on Aug 23, 2021. The device falls under product code QQC (Brain Stimulation Programming Planning Software.), a Class II device regulated under 21 CFR 882.5855.
Clearance details
- Decision
- DENG (De Novo granted)
- Decision Date
- Aug 23, 2021
- Date Received
- Feb 3, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Brain Stimulation Programming Planning Software.
- Device Class
- Class II
- Regulation Number
- 882.5855
- Review Panel
- NE
- Submission Type
- 510(k)
The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.