3560019

• FDA PMA P080025 decided 14 Mar 2011 Active· +1 more in the status table
• FDA GUDID UDI-DI 00643169103207 listed 23 Sep 2014 Listed

• • Ongoing Z-1704-2025 FDA Class II ·initiated 3 Apr 2025

  Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

• • Ongoing Z-0372-2025 FDA Class II ·initiated 18 Sep 2024 ·on shared PMA P080025

  The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.

• • Ongoing Z-2365-2023 FDA Class II ·initiated 6 Jul 2023

  Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.

• • Terminated Z-0998-2022 FDA Class II ·initiated 28 Feb 2022

  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.

• • Terminated Z-1147-2015 FDA Class II ·initiated 9 Jan 2015 ·on shared PMA P080025

  Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate.

• • Terminated Z-0037-2008 FDA Unclassified (pre-2012) ·initiated 25 Jun 2007

  A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .

• • Terminated Z-0040-2008 FDA Unclassified (pre-2012) ·initiated 25 Jun 2007

  Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 29 Sep 1997 Approved FDA PMA P970004
2. 25 Jun 2007 Recall initiated FDA recalls Z-0037-2008
3. 25 Jun 2007 Recall initiated FDA recalls Z-0040-2008
4. 14 Mar 2011 Approved FDA PMA P080025
5. 23 Sep 2014 Listed FDA GUDID 00643169103207
6. 9 Jan 2015 Recall initiated FDA recalls Z-1147-2015
7. 28 Feb 2022 Recall initiated FDA recalls Z-0998-2022
8. 6 Jul 2023 Recall initiated FDA recalls Z-2365-2023
9. 18 Sep 2024 Recall initiated FDA recalls Z-0372-2025
10. 3 Apr 2025 Recall initiated FDA recalls Z-1704-2025

Generic name

Personal device holder, single-use

Model / reference

3560019

Primary DI / UDI-DI

00643169103207

PMA number

P080025 ↗

P970004 ↗

FDA product code

EZW, QON

GMDN term

Personal device holder, single-use

Device class

Class III

Regulation number

876.5270

GUDID distribution status

In Commercial Distribution

Category: Personal device holder, single-use

Other devices filed under FDA product code QON.

• Axonics Sacral Neuromodulation System by Boston Scientific
• Neuspera Sacral Neuromodulation System by NEUSPERA MEDICAL, INC.
• Interstim Therapy System for Urinary Control by MEDTRONIC NEUROMODULATION
• Virtis Sacral Neuromodulation System by Cirtec Medical Corporation
• InterStim Therapy System, Verify Evaluation System by MEDTRONIC NEUROMODULATION

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