- Device
- InterStim® Therapy System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S246
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2022-01-13
- Decision code
- OK30
- Date received
- 2021-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of a new Distribution Center Sorter Tool (DCST) to check unopened active implantable devices returned from customers.