- Device
- InterStim™ Therapy System, Verify™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S350
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2026-08-14
- Decision code
- OK30
- Date received
- 2026-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of manufacturing controls for Intellis rechargeable lithium-ion batteries.