MEDTRONIC INTERSTIM THERAPY FOR BOWEL CONTROL
FDA premarket approval P080025/S068 · decided 2014-10-17
Approval details
- PMA number
- P080025
- Supplement
- S068
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC INTERSTIM THERAPY FOR BOWEL CONTROL
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2014-04-21
- Decision date
- 2014-10-17
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR CHANGES TO THE MODEL 3037 ICON PATIENT CONTROLLER USED FOR MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL AND BOWEL CONTROL.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |