{
  "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": "2026-10-19",
    "results": {
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  "results": [
    {
      "pma_number": "P970003",
      "supplement_number": "S247",
      "applicant": "LivaNova USA, Inc.",
      "street_1": "100 Cyberonics Blvd.",
      "street_2": "",
      "city": "Houston",
      "state": "TX",
      "zip": "77058",
      "zip_ext": "",
      "generic_name": "Stimulator, autonomic nerve, implanted for epilepsy",
      "trade_name": "VNS THERAPY SYSTEM",
      "product_code": "LYJ",
      "advisory_committee": "NE",
      "advisory_committee_description": "Neurology",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2025-03-12",
      "decision_date": "2025-05-02",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval for replacement of the reed switch with giant magnetoresistor sensor for utilizing magnet mode within the implantable pulse generator (Model M1000 and M1000-D) as a corrective action for recall Z-1072-2025",
      "openfda": {
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        "medical_specialty_description": "Unknown",
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