- Device
- InterStim TM Therapy System; Verify™ Evaluation System; InterStim SNS Bowel Lead Model 978B1
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S346
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2026-06-04
- Decision code
- OK30
- Date received
- 2026-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for additional in-process visual inspections for the braided lead body subassemblies