{
  "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": "2026-10-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "pma_number": "P030036",
      "supplement_number": "S159",
      "applicant": "Medtronic Cardiac Rhythm Disease Management",
      "street_1": "8200 Coral Sea St. N.E",
      "street_2": "",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes",
      "trade_name": "Anchoring Sleeve Kit; SelectSecure Lead",
      "product_code": "NVN",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2026-03-31",
      "decision_date": "2026-04-15",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "to reduce the bioburden monitoring frequency from bi-weekly to monthly",
      "openfda": {
        "device_name": "Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "9610139",
          "2182208",
          "2124215",
          "3006705815",
          "2017865",
          "3009380063",
          "3004209178",
          "1000165971",
          "2649622",
          "3003932293",
          "3016678045",
          "3003120897",
          "2030624",
          "3008159616",
          "3033257494",
          "1028232",
          "2648729",
          "3008494315",
          "9614453",
          "3008973940",
          "9616693",
          "3011181002",
          "2032521",
          "3005029049",
          "3002806603",
          "3013288201",
          "3018094310"
        ],
        "fei_number": [
          "2182208",
          "2124215",
          "3006705815",
          "2017865",
          "3004369318",
          "3009380063",
          "1000165971",
          "2649622",
          "3003932293",
          "3016678045",
          "3003120897",
          "3008159616",
          "3002806500",
          "3033257494",
          "1028232",
          "2648729",
          "3008973940",
          "3002618605",
          "3011181002",
          "3003574398",
          "3005029049",
          "3000206435",
          "3002806603",
          "3013288201",
          "3008377825",
          "3018094310",
          "3002807576"
        ]
      }
    }
  ]
}