{
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    "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": "S013",
      "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",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2022-03-01",
      "decision_date": "2022-11-15",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for the AtriCure Multifunctional Ablation Generator (MAG) as part of the Synergy Ablation System for use with the Isolator® Synergy Clamp™ (OLL2 and OSL2).",
      "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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