MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
FDA premarket approval P080025/S092 · decided 2016-10-04
Approval details
- PMA number
- P080025
- Supplement
- S092
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2015-04-20
- Decision date
- 2016-10-04
- Days to decision
- 533 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a labeling update to incorporate data from the now completed, randomized 6 month cohort (Phase I) and 12 month data from the ongoing, nonrandomized study cohort (Phase II).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |