{
  "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": "P200002",
      "supplement_number": "S012",
      "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": "EPi-Sense Guided Coagulation System",
      "product_code": "OCM",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Postapproval Study Protocol",
      "expedited_review_flag": "N",
      "date_received": "2025-07-23",
      "decision_date": "2025-10-07",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval of a revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P200002.",
      "openfda": {
        "device_name": "Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "2025851",
          "1047843",
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}