PMA P080025S351
- Device
- lnterStim™ Therapy System, Verify™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S351
- Product code
- QON
- Decision date
- 2026-10-06
- Classification
- Gastroenterology, Urology
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- a new stand-alone torque wrench kit configuration (Model B31020-T)
Current openFDA PMA Record#
- Device
- lnterStim™ Therapy System, Verify™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S351
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2026-10-06
- Decision code
- APPR
- Date received
- 2026-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a new stand-alone torque wrench kit configuration (Model B31020-T)