- Device
- InterStim Therapy System and Veify Evaluation System (SNS Bowel Programming Systems)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S227
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2021-04-09
- Decision code
- OK30
- Date received
- 2021-03-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a test application to the DistributionCenter Sorter Tool (DCST) for Model 97810 InterStim Micro.