{
  "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": {
      "skip": 0,
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Austin",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "2621 Ridgepoint Dr., Suite 100",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PST",
      "openfda": {
        "device_name": "Aortic Annuloplasty Ring",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3800",
        "device_class": "2",
        "registration_number": [
          "3003477135",
          "1424263",
          "3005687633",
          "3019892983"
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          "3003477135",
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          "3003015552",
          "3019892983"
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      },
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      "applicant": "Biostable Science & Engineering, Inc.",
      "decision_date": "2017-03-21",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm",
      "advisory_committee": "CV",
      "contact": "Julie  Thomas",
      "expedited_review_flag": "",
      "k_number": "K163608",
      "state": "TX",
      "date_received": "2016-12-21",
      "review_advisory_committee": "CV",
      "postal_code": "78754",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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  ]
}