{
  "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": "P240006",
      "supplement_number": "S008",
      "applicant": "Biosense Webster, Inc.",
      "street_1": "31 Technology Dr.",
      "street_2": "Suite 200",
      "city": "Irvine",
      "state": "CA",
      "zip": "91618",
      "zip_ext": "",
      "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
      "trade_name": "VARIPULSE Bi-Directional Catheter",
      "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": "2025-04-30",
      "decision_date": "2025-06-05",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "duplication of the VARIPULSE Bi-Directional Catheter manufacturing line at the Juarez, Mexico site",
      "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"
      }
    }
  ]
}