{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Plymouth",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "2950 Xenium Ln. N., #120",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "DTB",
      "openfda": {
        "registration_number": [
          "1720929",
          "2183787",
          "1028232",
          "3006705815",
          "1035166",
          "3013288201",
          "2032521",
          "3009380063",
          "2183744",
          "2649622",
          "3016678045",
          "3008973940",
          "9616693",
          "9610139",
          "3008988055",
          "3008494315",
          "3005029049",
          "2124215",
          "3018094310",
          "1061927",
          "2017865",
          "2182208",
          "2648729",
          "1928237"
        ],
        "fei_number": [
          "1720929",
          "2183787",
          "1028232",
          "3006705815",
          "1035166",
          "3013288201",
          "3009380063",
          "2183744",
          "2649622",
          "3016678045",
          "3008973940",
          "3002618605",
          "3008988055",
          "3005029049",
          "2124215",
          "3018094310",
          "3003574398",
          "3000203000",
          "2017865",
          "3008377825",
          "2182208",
          "2648729",
          "3002806500",
          "1928237"
        ],
        "device_name": "Permanent Pacemaker Electrode",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3680",
        "device_class": "3"
      },
      "zip_code": "55441",
      "applicant": "Ela Medical, Inc.",
      "decision_date": "2000-04-10",
      "decision_code": "ST",
      "country_code": "US",
      "device_name": "STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS",
      "advisory_committee": "CV",
      "contact": "CATHERINE G GOBLE",
      "expedited_review_flag": "",
      "k_number": "K993448",
      "state": "MN",
      "date_received": "1999-10-12",
      "review_advisory_committee": "CV",
      "postal_code": "55441",
      "decision_description": "Substantially Equivalent - Subject to Tracking Reg.",
      "clearance_type": "Traditional"
    }
  ]
}