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CD9000A

by Medtronic, Inc.

Ref CD9000A

CD9000A is a Class III device made by Medtronic, Inc., registered in EUDAMED on 14 Jul 2026 (Basic UDI-DI 0199309B0000034K2) with CE/MDR certificate G70 039709 1509 valid until 27 Dec 2028, approved under FDA PMA P080025 on 14 Mar 2011 (1 earlier submission) and listed in FDA GUDID since 6 May 2024 (UDI-DI 00763000869359), active as of 23 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

27 Dec 2028

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0199309B0000034K2 Basic UDI-DI 00763000869359UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000869359 UDI-DI Date6 May 2024ListedStatusListed 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 0199309B0000034K2 registered 14 Jul 2026 Active· +1 more in the status table
  • FDA PMA P080025 decided 14 Mar 2011 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00763000869359 listed 6 May 2024 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 039709 1509 Active Supplemented

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    15 Jun 2026
    Expires
    27 Dec 2028
    Reason
    Add device or group

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

13 dated events

  1. Approved FDA PMA P080025
  2. Recall initiated FDA recalls Z-1147-2015
  3. Recall initiated FDA recalls Z-0998-2022
  4. Recall initiated FDA recalls Z-2365-2023
  5. Listed FDA GUDID 00763000869359
  6. Recall initiated FDA recalls Z-0372-2025
  7. Recall initiated FDA recalls Z-1704-2025
  8. Certificate issued EUDAMED G70 039709 1509
  9. Registered EUDAMED 0199309B0000034K2
  10. Certificate expires EUDAMED G70 039709 1509

3 earlier events 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
Secondary battery
Device name
Dock
Model / reference
CD9000A
Primary DI / UDI-DI
00763000869359
Basic UDI-DI
0199309B0000034K2
PMA number
FDA product code
EZW, QON
EMDN code
J020480 Sacral spine implantable neurostimulators - accessories
GMDN term
Secondary battery
Device class
Class III
Regulation number
876.5270
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Secondary battery

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 IMPLANTABLE NEUROSTIMULATORS.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)