InterStim Therapy System, Verify Evaluation System
FDA premarket approval P080025/S210 · decided 2020-11-03
Approval details
- PMA number
- P080025
- Supplement
- S210
- 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
- 2020-08-21
- Decision date
- 2020-11-03
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval to add the use of tin-lead plating for the terminations of both ends of the T8 tantalum capacitors and for the Model 97810 InterStim Micro INS only, change the solder paste stencil tooling for the 1411 capacitor size to increase the amount of solder paste to match the mount used on other capacitor case sizes.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |