INTERSTIM THERAPY FOR BOWEL CONTROL
FDA premarket approval P080025/S074 · decided 2014-07-25
Approval details
- PMA number
- P080025
- Supplement
- S074
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTERSTIM THERAPY FOR BOWEL CONTROL
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2014-06-27
- Decision date
- 2014-07-25
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR CHANGES TO THE LABELING TO ADD A WARNING REGARDING THE RISK OF INCREASED OR UNCONTROLLED BLEEDING AND THE USE OF ANTICOAGULANTS PRIOR TO SURGERY FOR INTERSTIM THERAPY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |