{
  "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": "2026-07-27",
    "results": {
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      "pma_number": "P130013",
      "supplement_number": "S043",
      "applicant": "Boston Scientific Corp",
      "street_1": "One Scimed Pl.",
      "street_2": "",
      "city": "Maple Grove",
      "state": "MN",
      "zip": "55311",
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      "generic_name": "System, appendage closure, left atrial",
      "trade_name": "WATCHMAN™ and WATCHMAN FLX™ Left Atrial Appendage Closure Devices with Delivery Systems",
      "product_code": "NGV",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2021-03-31",
      "decision_date": "2022-09-02",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for the addition of dual antiplatelet therapy (DAPT) as an alterative post-implant antithrombotic medication regimen.",
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        "device_name": "System, Appendage Closure, Left Atrial",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
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  ]
}