{
  "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": "Lake Oswego",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "6024 Jean Rd.",
      "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": "97035",
      "applicant": "Biotronik, Inc.",
      "decision_date": "1998-07-22",
      "decision_code": "ST",
      "country_code": "US",
      "device_name": "RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000",
      "advisory_committee": "CV",
      "contact": "LAUREN L FOOTE CHRISTENSEN",
      "expedited_review_flag": "",
      "k_number": "K981083",
      "state": "OR",
      "date_received": "1998-03-24",
      "review_advisory_committee": "CV",
      "postal_code": "97035",
      "decision_description": "Substantially Equivalent - Subject to Tracking Reg.",
      "clearance_type": "Traditional"
    }
  ]
}