{
  "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": "P010015",
      "supplement_number": "S585",
      "applicant": "Medtronic, Inc.",
      "street_1": "8200 Coral Sea St. N.E",
      "street_2": "Ms Mvs11",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Implantable pulse generator, pacemaker (non-CRT)",
      "trade_name": "Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C",
      "product_code": "LWP",
      "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": "2026-03-25",
      "decision_date": "2026-04-23",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "updates to the software programs on the Medium Rate battery line at supplier, Medtronic Energy and Component Center",
      "openfda": {
        "device_name": "Implantable Pulse Generator, Pacemaker (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "9610139",
          "2182208",
          "2124215",
          "3006705815",
          "2017865",
          "3008483389",
          "3009380063",
          "3004209178",
          "1000165971",
          "2649622",
          "1220452",
          "3003932293",
          "1450662",
          "3003120897",
          "2135338",
          "2133641",
          "3008159616",
          "2024024",
          "3033257494",
          "1028232",
          "2648729",
          "3005334138",
          "3008494315",
          "3013500228",
          "9614453",
          "3012552532",
          "3008973940",
          "9616693",
          "2032521",
          "1721676",
          "3002806603",
          "3013288201",
          "3013596024",
          "3018094310",
          "3004105270"
        ],
        "fei_number": [
          "2182208",
          "2124215",
          "3006705815",
          "2017865",
          "3004369318",
          "3008483389",
          "3009380063",
          "1000165971",
          "2649622",
          "1220452",
          "3003932293",
          "3000203466",
          "1450662",
          "3003120897",
          "3008159616",
          "2024024",
          "3002806500",
          "3033257494",
          "1028232",
          "2648729",
          "3005334138",
          "3013500228",
          "3005700659",
          "3012552532",
          "3008973940",
          "3002618605",
          "3003574398",
          "1721676",
          "3002806603",
          "3013288201",
          "3013596024",
          "3008377825",
          "3018094310",
          "3004105270",
          "3002807576"
        ]
      }
    }
  ]
}