nterStim Therapy System, Verify Evaluation System
FDA premarket approval P080025/S321 · decided 2025-11-04
Approval details
- PMA number
- P080025
- Supplement
- S321
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- nterStim Therapy System, Verify Evaluation System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2025-06-04
- Decision date
- 2025-11-04
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- implement a change to the Amine Value upper specification limit, correct a typographical error in the Iodine value test method name, and add the initial shelf-life definition
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |