- Device
- InterStim Therapy System, Verify Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S223
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2021-04-09
- Decision code
- APPR
- Date received
- 2021-01-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design change to the foramen needles provided with various InterStim Therapy lead kits and separately packaged kits.