{
  "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": "2026-10-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "pma_number": "P230030",
      "supplement_number": "S001",
      "applicant": "Farapulse, Inc.",
      "street_1": "3715 Haven Ave.",
      "street_2": "Suite 110",
      "city": "Menlo Park",
      "state": "CA",
      "zip": "94025",
      "zip_ext": "",
      "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
      "trade_name": "Farapulse Pulsed Field Ablation System",
      "product_code": "QZI",
      "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": "2024-02-13",
      "decision_date": "2024-03-13",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "addition of parametric release for the BSC856 ethylene oxide sterilization cycle at the BSC Coventry, RI Facility",
      "openfda": {
        "registration_number": [
          "3012693387",
          "3017060084",
          "3007029079",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "3011120183",
          "9673241",
          "3001592626",
          "2124215",
          "2182269",
          "3009380063",
          "3000279201",
          "3007603855",
          "3005012805",
          "2183744",
          "1000121056",
          "3008328679",
          "3004593495",
          "3002807314",
          "3007648309",
          "3004859241",
          "3002648230",
          "3009243923",
          "9680579",
          "2024024",
          "3009504230",
          "3012520654",
          "3012263546",
          "3012260771",
          "3004016520",
          "3012179728",
          "3016245399",
          "2182208",
          "1319639",
          "1721983",
          "2184149",
          "9681260",
          "3013300026",
          "2032112",
          "3004105270",
          "3013403214",
          "9612164"
        ],
        "fei_number": [
          "3012693387",
          "3017060084",
          "3007029079",
          "3005334138",
          "3008452825",
          "1000203464",
          "1721686",
          "3008093809",
          "1928237",
          "3011120183",
          "1000138054",
          "3003248396",
          "3001592626",
          "2124215",
          "2182269",
          "3009380063",
          "3000279201",
          "3007603855",
          "3005012805",
          "2183744",
          "1000121056",
          "3008328679",
          "3004593495",
          "3002807314",
          "3003076831",
          "3007648309",
          "3004859241",
          "3002648230",
          "3002806434",
          "3009243923",
          "1000064530",
          "2024024",
          "3009504230",
          "3012520654",
          "3012263546",
          "3012260771",
          "3002806565",
          "1000139754",
          "3004016520",
          "3012179728",
          "3016245399",
          "2182208",
          "3013300026",
          "3004105270",
          "3013403214"
        ],
        "device_name": "Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}