{
  "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,
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  "results": [
    {
      "pma_number": "P100046",
      "supplement_number": "",
      "applicant": "AtriCure, Inc.",
      "street_1": "7555 Innovation Way",
      "street_2": "",
      "city": "Mason",
      "state": "OH",
      "zip": "45040",
      "zip_ext": "",
      "generic_name": "Surgical cardiac ablation device, for treatment of atrial fibrillation",
      "trade_name": "ATRICURE SYNERGY ABLATION SYSTEM",
      "product_code": "OCM",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "Y",
      "date_received": "2010-12-23",
      "decision_date": "2011-12-14",
      "docket_number": "11M-0910",
      "fed_reg_notice_date": "2011-12-19",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE ATRICURE SYNERGY ABLATION SYSTEM. THIS DEVICE IS INDICATED FOR THE ABLATION OF CARDIAC TISSUE FOR THETREATMENT OF PERSISTENT ATRIAL FIBRILLATION (SUSTAINED BEYOND SEVEN DAYS, OR LASTING LESS THAN SEVEN DAYS BUT NECESSITATING PHARMACOLOGIC OR ELECTRICAL CARDIOVERSION) OR LONGSTANDING PERSISTENT ATRIALFIBRILLATION (CONTINUOUS ATRIAL FIBRILLATION OF GREATER THAN ONE YEAR DURATION) IN PATIENTS WHO ARE UNDERGOING OPEN CONCOMITANT CORONARY ARTERY BYPASS GRAFTING AND/OR VALVE REPLACEMENT OR REPAIR.",
      "openfda": {
        "device_name": "Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3010653929",
          "3011706110",
          "2182291",
          "2133810",
          "1047843",
          "1225698",
          "2528981",
          "1036836",
          "2025851"
        ],
        "fei_number": [
          "3010653929",
          "3011706110",
          "2182291",
          "3000203066",
          "1047843",
          "2528981",
          "3001451473",
          "1036836",
          "2025851"
        ]
      }
    }
  ]
}