{
  "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": "2026-11-02",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "OKR",
      "openfda": {},
      "review_panel": "CV",
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      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Cardiovascular",
      "device_class": "3",
      "definition": "A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow  for <6 hours. The device is either totally or partially implanted in the body.",
      "regulation_number": "870.3545",
      "implant_flag": "N",
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}