{
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    "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": "S015",
      "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 Isolator Clamp, AtriCure Long Clamp, AtriCure Synergy Clamp",
      "product_code": "OCM",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2023-02-21",
      "decision_date": "2023-03-23",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "Alternative epoxy backfilling process to be used on the overmolded insulators found on the sterile OSL2 and OLL2 handpieces.",
      "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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