{
  "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": "P230017",
      "supplement_number": "S009",
      "applicant": "Medtronic, Inc.",
      "street_1": "8200 Coral Sea St. N.E",
      "street_2": "",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
      "trade_name": "PulseSelect Pulsed Field Ablation (PFA) system",
      "product_code": "QZI",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2025-11-07",
      "decision_date": "2026-02-17",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "the PulseSelect System for an update for R-wave gating of PulseSelect Pulsed Field Ablation (PFA) energy deliveries to be made optional",
      "openfda": {
        "device_name": "Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3013403214",
          "2032112",
          "2124215",
          "9681260",
          "3012263546",
          "2182208",
          "1928237",
          "3009380063",
          "3000279201",
          "2182269",
          "3012179728",
          "3011120183",
          "3017060084",
          "3009243923",
          "3007648309",
          "3007029079",
          "1721983",
          "3007603855",
          "3009504230",
          "3004016520",
          "3005012805",
          "2024024",
          "3002648230",
          "3005334138",
          "3008452825",
          "2183744",
          "3012520654",
          "1319639",
          "9680579",
          "9673241",
          "1721686",
          "3016245399",
          "3004593495",
          "3012260771",
          "3012693387",
          "9612164",
          "2184149",
          "3004859241",
          "1000121056",
          "3013300026",
          "3002807314",
          "3008093809",
          "3004105270",
          "3001592626",
          "3008328679"
        ],
        "fei_number": [
          "3013403214",
          "2182208",
          "2124215",
          "3012263546",
          "3000279201",
          "3002806565",
          "3009380063",
          "1928237",
          "2182269",
          "1000203464",
          "3002806434",
          "3012179728",
          "3011120183",
          "3017060084",
          "3009243923",
          "1000139754",
          "3007648309",
          "3007029079",
          "3007603855",
          "3009504230",
          "3004016520",
          "3005012805",
          "2024024",
          "3002648230",
          "3005334138",
          "3008452825",
          "2183744",
          "3012520654",
          "3003076831",
          "1721686",
          "3016245399",
          "3004593495",
          "3012260771",
          "3012693387",
          "3003248396",
          "1000138054",
          "3004859241",
          "1000121056",
          "3013300026",
          "3002807314",
          "3008093809",
          "1000064530",
          "3004105270",
          "3001592626",
          "3008328679"
        ]
      }
    }
  ]
}