INTERSTIM THERAPY FOR BOWEL CONTROL
FDA premarket approval P080025/S049 · decided 2014-04-15
Approval details
- PMA number
- P080025
- Supplement
- S049
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- INTERSTIM THERAPY FOR BOWEL CONTROL
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2013-03-07
- Decision date
- 2014-04-15
- Days to decision
- 404 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR LABELING UPDATES TO INCORPORATE THE LONG-TERM DATA FROM THE FECAL INCONTINENCE POST-APPROVAL STUDY INTO THE INTERSTIM® THERAPY LABELING.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |