{
  "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": "P200028",
      "supplement_number": "S017",
      "applicant": "Medtronic, Inc.",
      "street_1": "8200 Coral Sea St.",
      "street_2": "",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
      "trade_name": "Loctite® 4206™",
      "product_code": "OAE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2023-02-23",
      "decision_date": "2023-05-24",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for changes to the raw materials used in the formulation of an adhesive used in DiamondTemp catheter manufacturing.",
      "openfda": {
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3005402529",
          "3013403214",
          "2032112",
          "2124215",
          "9681260",
          "3012263546",
          "2182208",
          "1928237",
          "3000279201",
          "2649622",
          "9611665",
          "3012179728",
          "3011120183",
          "3017060084",
          "3009243923",
          "9680001",
          "3007029079",
          "9617601",
          "1721983",
          "3007603855",
          "3009504230",
          "3004016520",
          "2024024",
          "2032098",
          "3015537323",
          "3002648230",
          "3005334138",
          "3008452825",
          "3012520654",
          "1319639",
          "3019807891",
          "3027305778",
          "9673241",
          "3010653929",
          "1721686",
          "3016245399",
          "3004593495",
          "1650907",
          "3012260771",
          "3012693387",
          "3004063494",
          "3012552532",
          "3006891611",
          "9612164",
          "1643817",
          "1225698",
          "1721676",
          "3010273872",
          "1222616",
          "3015544746",
          "2133810",
          "2184149",
          "3004859241",
          "1000121056",
          "3010705768",
          "3013300026",
          "3044156918",
          "2028523",
          "3002807314",
          "3008093809",
          "3015289131",
          "3017128979",
          "3004105270",
          "3001592626",
          "3008328679"
        ],
        "fei_number": [
          "3005402529",
          "3013403214",
          "2182208",
          "2124215",
          "3012263546",
          "3002534070",
          "3002806565",
          "1928237",
          "3000279201",
          "2649622",
          "3004105270",
          "3002806434",
          "3012179728",
          "3011120183",
          "3017060084",
          "3009243923",
          "1000139754",
          "3007029079",
          "3007603855",
          "3009504230",
          "3004016520",
          "2024024",
          "3000203066",
          "3015537323",
          "3002648230",
          "3005334138",
          "3008452825",
          "3002808445",
          "3002807095",
          "1000125147",
          "3012520654",
          "3003076831",
          "3002681132",
          "3019807891",
          "3027305778",
          "3010653929",
          "1721686",
          "3016245399",
          "3004593495",
          "3012260771",
          "3012693387",
          "3004063494",
          "3012552532",
          "1000120916",
          "3006891611",
          "3003248396",
          "3001451473",
          "1643817",
          "1000138054",
          "1721676",
          "3010273872",
          "3015544746",
          "3004859241",
          "1000121056",
          "3010705768",
          "3013300026",
          "3044156918",
          "3002807314",
          "3008093809",
          "3003058448",
          "3015289131",
          "3017128979",
          "1000064530",
          "3001592626",
          "3008328679"
        ]
      }
    }
  ]
}