InterStim® Therapy System, Verify® Evaluation System
FDA premarket approval P080025/S289 · decided 2024-01-11
Approval details
- PMA number
- P080025
- Supplement
- S289
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim® Therapy System, Verify® Evaluation System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2023-12-13
- Decision date
- 2024-01-11
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- to implement updates to the test equipment and method for battery electrolyte used in the device battery manufacturing process
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 |