Interm Therapy System, Verify Evaluation System (SNS Bowel)
FDA premarket approval P080025/S196 · decided 2019-10-13
Approval details
- PMA number
- P080025
- Supplement
- S196
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Interm Therapy System, Verify Evaluation System (SNS Bowel)
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2019-09-16
- Decision date
- 2019-10-13
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Add a new qualified laboratory for bioburden and endotoxin testing and lower the endotoxin testing limit for two components.
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 |