{
  "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": "P100046",
      "supplement_number": "S010",
      "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": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2018-12-28",
      "decision_date": "2019-06-26",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval of labeling updates to include the results of the ABLATE Post Approval Study (PAS) for the AtriCure Synergy Ablation System.",
      "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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