Interstim®
Lead 3057-1SC Test Screener 1PK US Bowel
1manufacturer
88catalogue numbers in this listing
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 | 2017-05-22 |
| Record revised | 2020-04-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature -30 to 135 °F; Storage environment temperature -34 to 57 °C |
| Sizes | Length 8.8 to 218 cm; length 3.5 to 16 in |
| Distribution end date | 2025-10-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3023 | In distribution | ||
| 041839 | Length 12.6 cm | 2 | In distribution |
| 041828 | Length 9.0 cm | 6 | In distribution |
| 309201 | Length 12.0 in | In distribution | |
| 3889-33 | Length 33.0 cm | In distribution | |
| 367675 | 6 | In distribution | |
| 3065USC | Length 41.0 cm | In distribution | |
| 041838 | Length 8.8 cm | 6 | In distribution |
| 306001 | Length 30.5 cm | In distribution | |
| 357975 | Length 75.0 cm | 6 | In distribution |
| 309201 | Length 30.5 cm | In distribution | |
| 357625 | In distribution | ||
| 3560022 | Length 100.0 cm | In distribution | |
| 357664 | In distribution | ||
| 357506 | 6 | In distribution | |
| 357501 | In distribution | ||
| 3560030 | Length 100.0 cm | In distribution | |
| 3889-41 | Length 41.0 cm | In distribution | |
| 3560031 | In distribution | ||
| 367675 | 6 | In distribution | |
| 357937 | Length 37.0 cm | 6 | In distribution |
| 357625 | Length 25.0 cm | In distribution | |
| 3023 | In distribution | ||
| 041826 | 10 | In distribution | |
| 357501 | In distribution | ||
| 357975 | 6 | In distribution | |
| 3065USC | In distribution | ||
| 041827 | In distribution | ||
| 306001 | Length 30.5 cm | In distribution | |
| 357506 | 6 | In distribution | |
| 367675 | Length 75.0 cm | 6 | In distribution |
| 367637 | 6 | In distribution | |
| 357664 | Length 64.0 cm | In distribution | |
| 305901 | Withdrawn | ||
| 3057-1SC | Withdrawn | ||
| 357937 | 6 | Withdrawn | |
| 357501 | Length 218.0 cm | Withdrawn | |
| 041831 | 6 | Withdrawn | |
| 3889-28 | Length 28.0 cm | Withdrawn | |
| 3093-41 | Length 41.0 cm | Withdrawn | |
| 3057-1SC | Withdrawn | ||
| 041826 | 10 | Withdrawn | |
| 3889-28 | Length 28.0 cm | Withdrawn | |
| 3058 | Withdrawn | ||
| 3095-25 | Length 25.0 cm | Withdrawn | |
| 309101 | Withdrawn | ||
| 041826 | 10 | Withdrawn | |
| 3095-25 | Length 25.0 cm | Withdrawn | |
| 3889-33 | Length 33.0 cm | Withdrawn | |
| 3889-28 | Length 28.0 cm | Withdrawn | |
| 3095-10 | Length 10.0 cm | Withdrawn | |
| 3058 | Withdrawn | ||
| 309101 | Withdrawn | ||
| 305901 | Withdrawn | ||
| 3093-28 | Length 28.0 cm | Withdrawn | |
| 041829 | Length 12.5 cm | 6 | Withdrawn |
| 3095-10 | Length 10.0 cm | Withdrawn | |
| 3889-41 | Withdrawn | ||
| 309101 | Withdrawn | ||
| 3889-41 | Length 41.0 cm | Withdrawn | |
| 041829 | 6 | Withdrawn | |
| 041828 | Length 9.0 cm | 6 | Withdrawn |
| 3093-33 | Length 33.0 cm | Withdrawn | |
| 3095-51 | Length 51.0 cm | Withdrawn | |
| 305901 | Withdrawn | ||
| 3889-33 | Length 33.0 cm | Withdrawn | |
| 3095-51 | Length 51.0 cm | Withdrawn | |
| 041831 | 6 | Withdrawn | |
| 3093-33 | Length 33.0 cm | Withdrawn | |
| 3889-28 | Withdrawn | ||
| 367637 | Length 37.0 cm | 6 | Withdrawn |
| 041829 | Length 5.0 in | 6 | Withdrawn |
| 041828 | 6 | Withdrawn | |
| 3889-28 | Length 28.0 cm | Withdrawn | |
| 3093-28 | Length 28.0 cm | Withdrawn | |
| 041828 | Length 9.0 cm | 6 | Withdrawn |
| 3065USC | Withdrawn | ||
| 3095-51 | Length 51.0 cm | Withdrawn | |
| 3065USC | Withdrawn | ||
| 357506 | Length 218.0 cm | 6 | Withdrawn |
| 3889-33 | Withdrawn | ||
| 357975 | 6 | Withdrawn | |
| 3095-25 | Length 25.0 cm | Withdrawn | |
| 3093-41 | Length 41.0 cm | Withdrawn | |
| 3889-41 | Length 41.0 cm | Withdrawn | |
| 3889-33 | Length 33.0 cm | Withdrawn | |
| 3095-10 | Length 10.0 cm | Withdrawn | |
| 041826 | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Interstim® II | Medtronic, Inc. | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medtronic Neuromodulation | UDI-DI | 2023-07-06 | Class II | Under Investigation by firm | Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date. | 360 packs (36 kits of 10 packs each) |
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.