InterStim Therapy System and Verify Evaluation System (SNM Urinary and Bowel)
FDA premarket approval P080025/S188 · decided 2019-07-25
Approval details
- PMA number
- P080025
- Supplement
- S188
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- InterStim Therapy System and Verify Evaluation System (SNM Urinary and Bowel)
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2019-06-26
- Decision date
- 2019-07-25
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the alignment of the labeling to an updated Risk Management process. This included addition of adverse events (e.g., changes in sexual function) and additional language to describe the impact of extreme program settings on battery longevity.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |