- Device
- InterStim™ Therapy System, Verify™ Evaluation System (SNS Urinary Programming Systems A510, A511, A520, A521)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S440
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2026-02-24
- Decision code
- APPR
- Date received
- 2025-11-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor software changes to Models A510, A520, A511, and A521 programming applications.