InterStim® Therapy System, Verify® Evaluation System
FDA premarket approval P080025/S280 · decided 2023-11-22
Approval details
- PMA number
- P080025
- Supplement
- S280
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- InterStim® Therapy System, Verify® Evaluation System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2023-06-12
- Decision date
- 2023-11-22
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- approval for updates to the existing approved RS5200 Recharger Kit, WR9220 Recharger, and CD9000 Dock, including mechanical, hardware, manufacturing, firmware design, and labeling changes
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |