- Device
- InterStim™ Therapy System, Verify™ Evaluation System (SNS Bowel Programming Systems A510, A511, A520, A521)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S335
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2026-02-24
- Decision code
- APPR
- Date received
- 2025-11-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor software changes to Models A510, A520, A511, and A521 programming applications.