{
  "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",
    "results": {
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  "results": [
    {
      "pma_number": "P150035",
      "supplement_number": "S038",
      "applicant": "ABBOTT MEDICAL",
      "street_1": "15900 Valley View Ct.",
      "street_2": "",
      "city": "Sylmar",
      "state": "CA",
      "zip": "91342",
      "zip_ext": "",
      "generic_name": "Leadless pacemaker",
      "trade_name": "Aveir VR (LSCD111); DR Delivery Catheter (LSCD201)",
      "product_code": "PNJ",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2026-03-02",
      "decision_date": "2026-05-29",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for a revised design for the AVEIR delivery catheters packaging trays and retainers as well as a shelf-life extension for both delivery catheters.",
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        "device_name": "Leadless Pacemaker",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3610",
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}