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37092

by Medtronic, Inc. 5 variants

37092 is a Class III device made by Medtronic, Inc., approved under FDA PMA P080025 on 14 Mar 2011, listed under FDA HDE H020007 (1 earlier submission) and listed in FDA GUDID since 23 Sep 2014 (UDI-DI 00613994747044), active as of 23 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA HDE

Valid until

No date given

No validity date on record

FDA recalls

3 ongoing

This device is named in the recall

Documents

PMA P080025

+2 more

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613994747044 UDI-DI Date23 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP080025 Date14 Mar 2011DecidedStatusActive
United StatesFDA HDE from GUDID NumberH020007 Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA PMA P080025 decided 14 Mar 2011 Active
  • FDA HDE H020007 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00613994747044 listed 23 Sep 2014 Listed

Recalls

5 recalls · 3 ongoing · FDA

    • 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

    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

    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.

Timeline

7 dated events

  1. Approved FDA PMA P080025
  2. Listed FDA GUDID 00613994747044
  3. Recall initiated FDA recalls Z-1147-2015
  4. Recall initiated FDA recalls Z-0998-2022
  5. Recall initiated FDA recalls Z-2365-2023
  6. Recall initiated FDA recalls Z-0372-2025
  7. Recall initiated FDA recalls Z-1704-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA HDE, FDA PMA Active

Specification

GUDID

Generic name
Multiple active implantable device programmer
Model / reference
37092
Primary DI / UDI-DI
00613994747044
PMA number
FDA product code
EZW, MHY, LGW, LKK, NHL, MRU, OLM, QON, PJS, MBX, SGS
GMDN term
Multiple active implantable device programmer
Device class
Class III
Regulation number
876.5270
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple active implantable device programmer

Cleared under the same submission (H020007)

and 8 more cleared under H020007

Cleared under the same submission (H050003)

and 8 more cleared under H050003

Similar devices in this category

Other devices filed under Multiple active implantable device programmer.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)