- Device
- InterStim Therapy System and Verify Evaluation System (SNS Bowel)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S228
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2021-06-22
- Decision code
- OK30
- Date received
- 2021-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the connector assembly resistance spot welding process window for the InterStim Micro INS (model 97810) at the Medtronics manufacturing facility located in Juncos, Puerto Rico.