MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
FDA premarket approval P080025 · decided 2011-03-14
Approval details
- PMA number
- P080025
- 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
- 2008-09-26
- Decision date
- 2011-03-14
- Days to decision
- 899 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE MEDTRONIC INTERSTIM THERAPY SYSTEM. THE DEVICE IS INDICATED FOR THE TREATMENT OF CHRONIC FECAL INCONTINENCE IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |