- Device
- InterStim TM Therapy System; Verify TM Evaluation System (97800)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S452
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2026-06-05
- Decision code
- OK30
- Date received
- 2026-05-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for expansion of incoming electrolyte salt acceptance limits. Specifically, to expand LiAsF6 electrolyte salt moisture content acceptance limit from: = 100 parts per million (ppm) to: = 200 ppm and expand LiAsF6 electrolyte salt insoluble acceptance limit from: = 20 ppm to: = 200 ppm