{
  "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": "P030031",
      "supplement_number": "S092",
      "applicant": "Biosense Webster, Inc.",
      "street_1": "31 Technology Dr., Suite 200",
      "street_2": "",
      "city": "Irvine",
      "state": "CA",
      "zip": "92618",
      "zip_ext": "",
      "generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
      "trade_name": "Vistag Surpoint External Process Unit (EPU)",
      "product_code": "OAD",
      "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": "2018-10-18",
      "decision_date": "2019-04-02",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval of a manufacturing site located at Flextronics, Ltd., Ramat Gavriel Industrial Zone, 2 Hamatechet St., Migdal Haemek 23108, P.O.B 867, Israel for the VISITAG SURPOINT External Processing Unit.",
      "openfda": {
        "registration_number": [
          "3017060084",
          "3007695959",
          "3007029079",
          "3006634485",
          "3010653929",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "1643817",
          "3011120183",
          "2028523",
          "9673241",
          "3001592626",
          "2124215",
          "2182269",
          "3000279201",
          "3010291427",
          "1650907",
          "1000121056",
          "3008328679",
          "3002807314",
          "2030404",
          "3010273872",
          "3015537323",
          "3004859241",
          "1721504",
          "3009243923",
          "3019807891",
          "3013581838",
          "3012520654",
          "3012260771",
          "3001763079",
          "3004016520",
          "3012179728",
          "3016245399",
          "3010280625",
          "2182208",
          "1319639",
          "1721983",
          "3010705768",
          "3004105270",
          "2184149",
          "9681260",
          "3013300026",
          "2032112",
          "9680001",
          "2032098",
          "3012552532",
          "3013403214",
          "9612164"
        ],
        "fei_number": [
          "3017060084",
          "3007695959",
          "3007029079",
          "3006634485",
          "3010653929",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "1643817",
          "3011120183",
          "1000138054",
          "3003248396",
          "3001592626",
          "2124215",
          "2182269",
          "1000519796",
          "3000279201",
          "3010291427",
          "3002681132",
          "1000121056",
          "3008328679",
          "3002807314",
          "3003076831",
          "3010273872",
          "3002808445",
          "3015537323",
          "3004859241",
          "3002806434",
          "1721504",
          "3009243923",
          "3019807891",
          "1000064530",
          "3013581838",
          "3012520654",
          "3012260771",
          "3002806565",
          "3001763079",
          "1000125147",
          "1000139754",
          "3004016520",
          "3012179728",
          "3016245399",
          "3010280625",
          "2182208",
          "3010705768",
          "3013300026",
          "3003058448",
          "3004105270",
          "3012552532",
          "3013403214"
        ],
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}