InterStim® Therapy System, Verify® Evaluation System, SNS Bowel Leads
FDA premarket approval P080025/S263 · decided 2022-09-23
Approval details
- PMA number
- P080025
- Supplement
- S263
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- InterStim® Therapy System, Verify® Evaluation System, SNS Bowel Leads
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2022-06-28
- Decision date
- 2022-09-23
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a change to update the pinch flash requirement on a distal section of the lead body assemblies and loosening the outer diameter (OD) tolerance on a proximal section of the lead body assemblies.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |