InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Bowel)
FDA premarket approval P080025/S215 · decided 2020-11-19
Approval details
- PMA number
- P080025
- Supplement
- S215
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Bowel)
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2020-10-20
- Decision date
- 2020-11-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Update the manufacturing execution system to FACTORYWorks Release 9.8.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |