InterStim Therapy System, Verify Evaluation System
FDA premarket approval P080025/S244 · decided 2021-12-08
Approval details
- PMA number
- P080025
- Supplement
- S244
- Supplement type
- Special (Immediate 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
- 2021-11-16
- Decision date
- 2021-12-08
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for revisions to physician and patient labeling to align with updated risk management process. The labeling changes include existing precautions elevated to warnings for packaging, single use and effects on other implanted devices.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |