- Device
- InterStim™ Therapy System; Verify™ Evaluation System (3550-05, 3560031, 3889, 978A1, 978B1)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S345
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2026-05-22
- Decision code
- OK30
- Date received
- 2026-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an alternate Tip Tunneling Guide manufacturer