Interstim® II
INS 3058 IS II Eman US
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | QON |
| Device type | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence |
| Device class | Class 3 |
| Regulation | 21 CFR 876.5270 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | P080025 |
| Record published | 2021-05-30 |
| Record revised | 2025-12-16 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3058 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Axonics | Axonics Modulation Technologies, Inc. | 22 |
| Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | Medtronic, Inc. | 6 |
| InterStim™ SureScan™ | Medtronic, Inc. | 5 |
| Verify™ | Medtronic, Inc. | 4 |
| InterStim™ X | Medtronic, Inc. | 1 |
| InterStim™ Micro SureScan™ MRI | Medtronic, Inc. | 1 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P080025 | 2024-12-13 | InterStim Therapy System, Verify Evaluation System | Medtronic Neuromodulation |
| P190006 | 2023-03-02 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.