{
  "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": {
      "skip": 0,
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  "results": [
    {
      "pma_number": "P970003",
      "supplement_number": "S236",
      "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": "SenTiva™ Model 1000 and SenTiva Duo™ Model 1000-D Generator Rhodium Reed Switch",
      "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": "2022-04-11",
      "decision_date": "2022-06-06",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for a change to the reed switch (i.e., change from Durel to Rhodium reed switch) that is used in the Model 1000 and M1000-D Generators.",
      "openfda": {
        "device_name": "Stimulator, Autonomic Nerve, Implanted For Epilepsy",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "1644487"
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        "fei_number": [
          "1000117004"
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