InterStim Therapy System, Verify Evaluation System
FDA premarket approval P080025/S292 · decided 2024-06-11
Approval details
- PMA number
- P080025
- Supplement
- S292
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- InterStim Therapy System, Verify Evaluation System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2024-03-19
- Decision date
- 2024-06-11
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- a minor change to the inner tray used for percutaneous extension kits
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |