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A511

by Medtronic, Inc.

Ref A511

A511 is a device classified as Class IIb in the EU and Class III in the US made by Medtronic, Inc., registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI 0763000B00019258J), approved under FDA PMA P080025 on 14 Mar 2011 (1 earlier submission) and listed in FDA GUDID since 14 Jan 2018 (UDI-DI 00643169834323), active as of 22 Oct 2026. 5 FDA recalls are linked to it.

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

CE MDR PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

PMA P080025

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00019258J Basic UDI-DI 00643169834323UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00643169834323 UDI-DI Date14 Jan 2018ListedStatusListed 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 0763000B00019258J registered 21 Aug 2026 Active
  • FDA PMA P080025 decided 14 Mar 2011 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00643169834323 listed 14 Jan 2018 Listed

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. Listed FDA GUDID 00643169834323
  6. Recall initiated FDA recalls Z-0998-2022
  7. Recall initiated FDA recalls Z-2365-2023
  8. Recall initiated FDA recalls Z-0372-2025
  9. Recall initiated FDA recalls Z-1704-2025
  10. Registered EUDAMED 0763000B00019258J

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
Wearable peripheral nerve electrical stimulator programmer
Device name
Clinician App
Model / reference
A511
Primary DI / UDI-DI
00643169834323
Basic UDI-DI
0763000B00019258J
PMA number
FDA product code
EZW, QON
EMDN code
U0780 Devices for the treatment of incontinence - accessories
GMDN term
Wearable peripheral nerve electrical stimulator programmer
Device class
Class IIb EUDAMED
Class III GUDID
Regulation number
876.5270
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class III

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Wearable peripheral nerve electrical stimulator 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

Also classified as Wearable peripheral nerve electrical stimulator programmer.

Similar devices in this category

Other devices filed under DEVICES FOR THE TREATMENT OF INCONTINENCE.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

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