- Device
- InterStim Therapy System SNS Bowel Neurostimulator
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S258
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2022-06-01
- Decision code
- OK30
- Date received
- 2022-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Operational/procedural changes to the final cleaning process at the internal manufacturing supplier.