{
  "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": "P250022",
      "supplement_number": "S006",
      "applicant": "ABBOTT MEDICAL",
      "street_1": "5050 Nathan Ln. N.",
      "street_2": "",
      "city": "Plymouth",
      "state": "MN",
      "zip": "55442",
      "zip_ext": "",
      "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
      "trade_name": "Volt PFA System",
      "product_code": "QZI",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2026-05-11",
      "decision_date": "2026-07-10",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval for additional manufacturing activities at Minnetonka, Minnesota",
      "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"
        ]
      }
    }
  ]
}