Stimulator, Electrical, Implantable, for Incontinence
Comm Handset TH90QFA Istim X A13 Eman US
1manufacturer
44catalogue 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) | P970004 |
| Record published | 2015-09-18 |
| Record revised | 2026-05-18 (version 9) |
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 -34 to 57 °C; Storage environment temperature -30 to 135 °F |
| Sizes | Length 10 to 58 cm; length 23 in |
| Distribution end date | 2025-10-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3037 | In distribution | |
| A520 | In distribution | |
| TH90QFA | In distribution | |
| A51200 | In distribution | |
| 3550-80 | In distribution | |
| TH90Q01 | In distribution | |
| TM90P01 | In distribution | |
| TH90PFA | In distribution | |
| CD9000 | In distribution | |
| RS5200 | In distribution | |
| A510 | In distribution | |
| A521 | In distribution | |
| WR9220-SVC | In distribution | |
| TH90Q01 | In distribution | |
| 37092 | In distribution | |
| 3560019 | In distribution | |
| A51300 | In distribution | |
| 3560019 | In distribution | |
| A52200 | In distribution | |
| 3537FA | In distribution | |
| A52300 | In distribution | |
| CD9000A | In distribution | |
| TH90Q01 | In distribution | |
| A90300 | In distribution | |
| TH90PFA | In distribution | |
| TH90P01 | In distribution | |
| TH90P01 | In distribution | |
| 3537FA | In distribution | |
| TH90QFA | In distribution | |
| TH90GFA | In distribution | |
| A511 | In distribution | |
| A52200 | In distribution | |
| TH90G01 | In distribution | |
| TM90P01 | In distribution | |
| 3537FA | In distribution | |
| 3037 | In distribution | |
| 7440 | Length 23.0 in | Withdrawn |
| 3095-25 | Length 25.0 cm | Withdrawn |
| 37092 | Withdrawn | |
| 3550-80 | Withdrawn | |
| 7440-23 | Length 23.0 in | Withdrawn |
| 3550-03 | Withdrawn | |
| 3095-51 | Length 51.0 cm | Withdrawn |
| 3095-10 | Length 10.0 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Interstim® | Medtronic, Inc. | 88 |
| Neuspera SNM System | Neuspera Medical, Inc. | 49 |
| 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
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medtronic Neuromodulation | UDI-DI | 2022-02-28 | Class II | Software Design Change | There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a ” Data Lost” notification being displayed. | 1005 units |
| Medtronic Neuromodulation | UDI-DI | 2021-11-04 | Class II | Other | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed. | 10,081 devices |
| Medtronic Neuromodulation | UDI-DI | 2019-05-15 | Class II | Software design | There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic’s smart programmer). | 13979 units |
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.