- Device
- InterStim® Therapy System, Verify® Evaluation System (SNS Urinary)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S375
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2022-11-16
- Decision code
- OK30
- Date received
- 2022-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a new external function used in finished device manufacturing that will automate pass or fail decisions on global monitors.