- Device
- InterStim® Therapy System, Verify® Evaluation System, InterStim Micro™ Implantable Neurostimulator
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S243
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2021-12-15
- Decision code
- OK30
- Date received
- 2021-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Revision to the manufacturing execution system used in several facilities for the subject devices.