- Device
- InterStim™ Therapy System, Verify™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S352
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2026-09-14
- Decision code
- OK30
- Date received
- 2026-08-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a manufacturing verification step for the WR9220A and P720R1 wireless rechargers