{
  "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",
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    {
      "pma_number": "P200002",
      "supplement_number": "S002",
      "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® ST Guided Coagulation System",
      "product_code": "OCM",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2022-02-17",
      "decision_date": "2022-08-16",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for a modified version of the coagulation probe called EPi-Sense ST, a new radiofrequency (RF) cable for use with EPi-Sense ST, and a modified cannula for use with both EPi-Sense and EPi-Sense ST.",
      "openfda": {
        "device_name": "Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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