- Device
- nterStim™ Therapy System, Verify™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S321
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2025-11-04
- Decision code
- APPR
- Date received
- 2025-06-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- implement a change to the Amine Value upper specification limit, correct a typographical error in the Iodine value test method name, and add the initial shelf-life definition