InterStim Therapy System and Verify Evaluation System (SNS Bowel Programming Systems)
FDA premarket approval P080025/S197 · decided 2020-07-30
Approval details
- PMA number
- P080025
- Supplement
- S197
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- InterStim Therapy System and Verify Evaluation System (SNS Bowel Programming Systems)
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2019-10-07
- Decision date
- 2020-07-30
- Days to decision
- 297 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval of the new InterStim Micro System with 1.5T and 3T full-body MR conditional labeling, an updated InterStim II System (including new SureScan MRI leads) with 1.5T and 3T full-body MR conditional labeling, an updated Verify Evaluation System that can accommodate newly developed leads, and related labeling updates.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |