Interstim® II
INS 3058 Interstim II Eman US GRC
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| 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 | EZW |
| Device type | Stimulator, Electrical, Implantable, For Incontinence |
| Device class | Class 3 |
| Regulation | 21 CFR 876.5270 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | P080025 |
| Record published | 2019-05-24 |
| Record revised | 2022-12-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -18 to 52 °C; Storage environment temperature 0 to 125 °F |
| Distribution end date | 2022-10-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3058 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Interstim® | Medtronic, Inc. | 88 |
| Neuspera SNM System | Neuspera Medical, Inc. | 49 |
| Stimulator, Electrical, Implantable, For Incontinence | Medtronic, Inc. | 44 |
| InterStim™ SureScan™ | Medtronic, Inc. | 13 |
| Axonics | Axonics Modulation Technologies, Inc. | 10 |
| Verify™ | Medtronic, Inc. | 5 |
| InterStim iCon | Medtronic, Inc. | 4 |
| Interstim® Twist-Lock Cable | Medtronic, Inc. | 2 |
| InterStim™ Micro | Medtronic, Inc. | 1 |
| Verify® External Neurostimulator | Medtronic, Inc. | 1 |
| InterStim™ X | Medtronic, Inc. | 1 |
| InterStim™ Micro SureScan™ | 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 |
|---|---|---|---|
| P240031 | 2026-08-21 | Neuspera Sacral Neuromodulation (SNM) System | Neuspera Medical, Inc. |
| P970004 | 2025-09-05 | InterStim® Therapy System; Verify® Evaluation System | Medtronic Neuromodulation |
| P170001 | 2023-01-11 | VIRTIS SACRAL NEUROMODULATION SYSTEM | Cirtec Medical |
| P180046 | 2022-01-04 | 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.