INTERSTIM THERAPY SYSTEM (FOR BOWEL CONTROL)
FDA premarket approval P080025/S123 · decided 2016-11-23
Approval details
- PMA number
- P080025
- Supplement
- S123
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERSTIM THERAPY SYSTEM (FOR BOWEL CONTROL)
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2016-08-25
- Decision date
- 2016-11-23
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for changes to two firmware requirements for Medtronics Model 3531 Verify External Neurostimulator.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |