InterStim® Sacral Nerve Stimulation Therapy System / Bowel Control
FDA premarket approval P080025/S148 · decided 2018-02-07
Approval details
- PMA number
- P080025
- Supplement
- S148
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- InterStim® Sacral Nerve Stimulation Therapy System / Bowel Control
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2017-08-21
- Decision date
- 2018-02-07
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for labeling updates to incorporate 5 year data from the InSite Post-Approval Study (Single Tined Lead (protocol 1634).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |