TH90PFA

• FDA PMA P970004 decided 29 Sep 1997 Active
• FDA GUDID UDI-DI 00763000433871 listed 21 May 2021 Listed

• • Ongoing Z-0372-2025 FDA Class II ·initiated 18 Sep 2024 ·on shared PMA P970004

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

• • 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 P970004

  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. 9 Jan 2015 Recall initiated FDA recalls Z-1147-2015
5. 21 May 2021 Listed FDA GUDID 00763000433871
6. 28 Feb 2022 Recall initiated FDA recalls Z-0998-2022
7. 18 Sep 2024 Recall initiated FDA recalls Z-0372-2025

Generic name

Multiple active implantable device programmer

Model / reference

TH90PFA

Primary DI / UDI-DI

00763000433871

PMA number

P970004 ↗

FDA product code

EZW, QON

GMDN term

Multiple active implantable device programmer

Device class

Class III

Regulation number

876.5270

GUDID distribution status

In Commercial Distribution

Category: Multiple active implantable device programmer

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