- Device
- InterStim® Therapy System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S348
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2026-06-12
- Decision code
- OK30
- Date received
- 2026-05-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add an alternate foramen needle manufacturer (Spectra Medical) for inclusion in the Medtronic Model 309201 InterStim™ Basic Evaluation (BE) Kit