- Device
- InterStim® Therapy System, Verify® Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S332
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2026-02-11
- Decision code
- APPR
- Date received
- 2025-08-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for a new solvent cleaner to be used in the Precision Machining & Manufacturing (PMM) processes