{
  "format": "devicerts.device.v1",
  "cite_as": "3560019, Medtronic, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/na-3560019-9a8d6a56 (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/na-3560019-9a8d6a56",
    "json_url": "https://devicerts.com/devices/na-3560019-9a8d6a56.json",
    "markdown_url": "https://devicerts.com/devices/na-3560019-9a8d6a56.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/na-3560019-9a8d6a56",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "3560019",
    "registry_name": "3560019",
    "url": "https://devicerts.com/devices/na-3560019-9a8d6a56",
    "manufacturer": {
      "name": "Medtronic, Inc.",
      "url": "https://devicerts.com/manufacturers/medtronic-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class III",
        "system": "US FDA"
      }
    ],
    "identifiers": [
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        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "00643169103207",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "PMA number",
        "values": [
          {
            "value": "P080025",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          },
          {
            "value": "P970004",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "EZW",
      "QON"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "31072",
        "term": "Personal device holder, single-use"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "00643169103207",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2014-09-23",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA PMA",
      "number": "P080025",
      "number_label": null,
      "device_udi_di": null,
      "date": "2011-03-14",
      "date_kind": "decision",
      "decision_code": "APPR",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    },
    {
      "registry": "GUDID",
      "region": "United States",
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      "number": "P970004",
      "number_label": null,
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      "date": "1997-09-29",
      "date_kind": "decision",
      "decision_code": "APPR",
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      "withdrawn": null,
      "status": "Active",
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      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
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    {
      "number": "Z-1704-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-04-03",
      "reason": "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.",
      "applies": "this device",
      "via": "P080025"
    },
    {
      "number": "Z-0372-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-09-18",
      "reason": "The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.",
      "applies": "shared submission",
      "via": "P080025"
    },
    {
      "number": "Z-2365-2023",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-07-06",
      "reason": "Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.",
      "applies": "this device",
      "via": "P080025"
    },
    {
      "number": "Z-0998-2022",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2022-02-28",
      "reason": "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.",
      "applies": "this device",
      "via": "P080025"
    },
    {
      "number": "Z-1147-2015",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2015-01-09",
      "reason": "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.",
      "applies": "shared submission",
      "via": "P080025"
    },
    {
      "number": "Z-0037-2008",
      "classification": "",
      "status": "terminated",
      "initiated": "2007-06-25",
      "reason": "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 .",
      "applies": "this device",
      "via": "P970004"
    },
    {
      "number": "Z-0040-2008",
      "classification": "",
      "status": "terminated",
      "initiated": "2007-06-25",
      "reason": "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).",
      "applies": "this device",
      "via": "P970004"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Generic name",
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        {
          "label": "Over-the-counter",
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          "label": "Convenience kit",
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          "label": "HCT/P",
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          "label": "Expiration date",
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}