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A52200

by Medtronic, Inc.

Ref A52200

A52200 is a Class III device made by Medtronic, Inc., registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI 0763000B00006617Y), approved under FDA PMA P080025 on 14 Mar 2011 (1 earlier submission) and listed in FDA GUDID since 19 Jun 2025 (UDI-DI 00763000970079), active as of 7 Nov 2026. 5 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

14 Jul 2027

CE MDR certificate

FDA recalls

3 ongoing

This device is named in the recall

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

PMA P080025

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00006617Y Basic UDI-DI 00763000970079UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000970079 UDI-DI Date19 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP080025 Date14 Mar 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00006617Y registered 21 Aug 2026 Active
  • FDA PMA P080025 decided 14 Mar 2011 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00763000970079 listed 19 Jun 2025 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 039709 1410 Expiring Supplemented Expires in 244 days

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    22 Sep 2026
    Expires
    14 Jul 2027
    Reason
    Change approved

Recalls

7 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 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.

Timeline

11 dated events

  1. Recall initiated FDA recalls Z-0037-2008
  2. Recall initiated FDA recalls Z-0040-2008
  3. Approved FDA PMA P080025
  4. Recall initiated FDA recalls Z-1147-2015
  5. Recall initiated FDA recalls Z-0998-2022
  6. Recall initiated FDA recalls Z-2365-2023
  7. Recall initiated FDA recalls Z-0372-2025
  8. Recall initiated FDA recalls Z-1704-2025
  9. Listed FDA GUDID 00763000970079
  10. Registered EUDAMED 0763000B00006617Y

1 earlier event are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Generic name
Multiple active implantable device programmer
Device name
Patient Therapy App for SNM Therapy
Model / reference
A52200
Primary DI / UDI-DI
00763000970079
Basic UDI-DI
0763000B00006617Y
PMA number
FDA product code
EZW, QON
EMDN code
J020792 Neurostimulators programmers - medical device software
GMDN term
Multiple active implantable device programmer
Device class
Class III
Regulation number
876.5270
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple active implantable device programmer

Cleared under the same submission (P080025)

and 8 more cleared under P080025

Cleared under the same submission (P970004)

and 8 more cleared under P970004

Similar devices in this category

Other devices filed under NEUROSTIMULATORS PROGRAMMERS AND ACCESSORIES.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)