- Device
- InterStim® Therapy System, Verify® Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S234
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2021-08-18
- Decision code
- OK30
- Date received
- 2021-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to in-process inspection acceptance activities for bubble and cosmetic foreign material detection.